-- phpMyAdmin SQL Dump -- version 2.6.1-pl2 -- http://www.phpmyadmin.net -- -- Serveur: 217.174.203.10 -- Généré le : Jeudi 05 Mai 2005 à 10:53 -- Version du serveur: 4.1.10 -- Version de PHP: 4.3.11-0.dotdeb.0 -- -- Base de données: `sid38` -- -- -------------------------------------------------------- -- -- Structure de la table `admin` -- DROP TABLE IF EXISTS `admin`; CREATE TABLE IF NOT EXISTS `admin` ( `admin_id` tinyint(4) NOT NULL auto_increment, `nom` varchar(20) NOT NULL default '', `pass` varchar(8) NOT NULL default '', PRIMARY KEY (`admin_id`), KEY `nom` (`nom`,`pass`) ) TYPE=MyISAM AUTO_INCREMENT=10 ; -- -- Contenu de la table `admin` -- INSERT INTO `admin` (`admin_id`, `nom`, `pass`) VALUES (1, 'medimark', 'nemelc'); INSERT INTO `admin` (`admin_id`, `nom`, `pass`) VALUES (2, 'siad', 'siad38'); INSERT INTO `admin` (`admin_id`, `nom`, `pass`) VALUES (8, 'fred', 'fredderf'); INSERT INTO `admin` (`admin_id`, `nom`, `pass`) VALUES (9, 'co-chairman', 'nemelc'); -- -------------------------------------------------------- -- -- Structure de la table `documents` -- DROP TABLE IF EXISTS `documents`; CREATE TABLE IF NOT EXISTS `documents` ( `doc_id` tinyint(4) NOT NULL auto_increment, `titre` varchar(50) NOT NULL default '', `lien` varchar(255) NOT NULL default '', `description` varchar(255) NOT NULL default '', PRIMARY KEY (`doc_id`) ) TYPE=MyISAM AUTO_INCREMENT=18 ; -- -- Contenu de la table `documents` -- INSERT INTO `documents` (`doc_id`, `titre`, `lien`, `description`) VALUES (1, 'Council Directive 93/42 EEC Consolidated 2003', '143_en_1993L0042_do_001_CONSOLIDE.pdf', 'EU Directive 93/42 concerning Medical Devices with updated amendments'); INSERT INTO `documents` (`doc_id`, `titre`, `lien`, `description`) VALUES (2, 'Directive 98/79/EC consolidated', '140_en_1998L0079_IVD_DIRECTIVE_CONSOLIDE.pdf', 'Directive 98/79/EC on in vitro diagnostic medical devices updated with amendments'); INSERT INTO `documents` (`doc_id`, `titre`, `lien`, `description`) VALUES (7, 'Compliance with Essential Requirements', 'compliance.php', '93/42 EEC directive'); INSERT INTO `documents` (`doc_id`, `titre`, `lien`, `description`) VALUES (9, 'MEDDEV 2.4/1 Rev.8 July 2001. Part 1', 'MEDDEV_2_2_4-1part1_07-2001MD_CLASSIFICATION_GUIDELINE.pdf', 'Guidelines for the classification of Medical Devices.'); INSERT INTO `documents` (`doc_id`, `titre`, `lien`, `description`) VALUES (10, 'MEDDEV 2.4/1 Rev.8 July 2001. Part 2', 'MEDDEV_2_2_4-1part2_07-2001_CLASIFF.pdf', 'Guidelines for the Classification of Medical Devices.'); INSERT INTO `documents` (`doc_id`, `titre`, `lien`, `description`) VALUES (11, 'MEDDEV 2.12-1 rev 4 April 2001', 'MEDDEV_04_2001_VIGILANCE_SYSTEM.pdf', 'Guidelines on a Medical Vigilance System'); INSERT INTO `documents` (`doc_id`, `titre`, `lien`, `description`) VALUES (12, 'MEDDEV 2.1/3 rev 2 July 2001', 'MEDDEV_2_1_3_07_2001_MEDICINAL _MD.pdf', 'Guidelines relative to Demarcation between AIMD Directive (90/385/EEC), MD Directive (93/42/EEC) and\r\n- Directive 65/65/EEC relating to Medicinal Products\r\n- Related Directives'); INSERT INTO `documents` (`doc_id`, `titre`, `lien`, `description`) VALUES (13, 'MEDDEV 2.1/5 June 1998', 'MEDDEV_2_1_5_JUNE_98_MD_MEASURING_FUNCTION .doc', 'Guidelines relating to Medical Devices with a Measuring Function'); INSERT INTO `documents` (`doc_id`, `titre`, `lien`, `description`) VALUES (15, 'Future update of the MD Directive', 'MMD-FUNCTIONING-finalreport05062002.pdf', 'June 2002: Report on the functionning of the Medical Devices Directive. Elements of this report will be fed into the overall review of the New Approach. See particularly section 7.1: Classification Rules.'); INSERT INTO `documents` (`doc_id`, `titre`, `lien`, `description`) VALUES (16, 'DIRECTIVE 2003/32/EC M.D / animal origin', '417_DIRECTIVE_2003_32_EC ANIMAL_TISSUE.pdf', 'New European Directive providing detailed \r\nspecifications as regards the requirements laid down in Council Directive 93/42/EEC (the Medical Device Directive) with respect to devices manufactured utilizing tissues of animal origin'); INSERT INTO `documents` (`doc_id`, `titre`, `lien`, `description`) VALUES (17, 'AIMD Directive 90/385 consolidated 2003', '177_DIRECTIVE_AIMD_en_1990L0385_do_001.pdf', 'Directive 90/385 concerning Active Implantable Medical Devices updated with amendments'); -- -------------------------------------------------------- -- -- Structure de la table `last` -- DROP TABLE IF EXISTS `last`; CREATE TABLE IF NOT EXISTS `last` ( `news_id` smallint(5) unsigned NOT NULL auto_increment, `quand` date NOT NULL default '0000-00-00', `titre` mediumtext NOT NULL, `description` longtext NOT NULL, `adresse` text NOT NULL, PRIMARY KEY (`news_id`) ) TYPE=MyISAM AUTO_INCREMENT=20 ; -- -- Contenu de la table `last` -- INSERT INTO `last` (`news_id`, `quand`, `titre`, `description`, `adresse`) VALUES (4, '2003-03-03', 'March 31, 2003: Last date for the mandatory Declaration and potential Tax on MDs and IVDs in France', 'All Manufacturers of MDs and IVDs who place their products on the French market shall send a declaration of their sales in France to the French Competent Authority. When the sales are above 718 560 US $, there is a tax to pay of 0.15% of this sales. If the declaration is not sent by March 31, 2003, huge penalties are given.', 'Last_News _Web _French_Tax 2003.pdf'); INSERT INTO `last` (`news_id`, `quand`, `titre`, `description`, `adresse`) VALUES (3, '2002-02-14', 'Where are we with the ISO 9001:2000 / ISO 13485 Revision ? ', 'ISO TC 210 WG 1 met jointly with GHTF SG 3 on October 13 to 15, 2001 in Barcelona. . . .\r\nHere is the summary of the Participant''s Meeting Report\r\n ', 'ISO_13485_Last_news.doc'); INSERT INTO `last` (`news_id`, `quand`, `titre`, `description`, `adresse`) VALUES (6, '2002-08-13', 'Update for EN ISO 13485 and EN ISO 14971', 'EN ISO 13485:2001 & EN ISO 13488:2001 are listed since July 31, 2002 as Harmonized Standards.\r\nEN ISO 14971:2001, Application of Risk Management to Medical Devices has been also listed as Harmonized Standard.', 'Last News August 12 02 Standards.pdf'); INSERT INTO `last` (`news_id`, `quand`, `titre`, `description`, `adresse`) VALUES (8, '2002-10-01', 'Future update of the MD Directive', 'The Medical Expert Group, which includes the Commission services, National Authorities, representatives from Notified Bodies, European Standards Organisations and industry have issued the Final Report on the functionning of the Medical Devices Directive. \r\nSee for example the issues on the classification rules in section 7.1', 'MMD-FUNCTIONING-finalreport05062002.pdf'); INSERT INTO `last` (`news_id`, `quand`, `titre`, `description`, `adresse`) VALUES (9, '2003-03-03', 'E.U. may reclassify joint replacement products', 'The European Commission is expected to recommend that joint replacements be reclassified into the European Union''s highest risk category, Class III. The request, made by the English and French device agencies, will increase costs for devicemakers because compliance is more onerous and costly. Joint replacements are currently in Class IIb (medium-high risk), with some components in Class IIa (medium-low risk).', 'MMENEWS June 2003 implants.pdf'); INSERT INTO `last` (`news_id`, `quand`, `titre`, `description`, `adresse`) VALUES (10, '2003-05-07', 'Commission Directive 2003 32 EC: Medical Devices / Animal Origin ', 'The European Commission has published a new Directive providing detailed\r\nspecifications as regards the requirements laid down in Council Directive\r\n93/42/EEC (the Medical Device Directive) with respect to devices\r\nmanufactured utilizing tissues of animal origin. The main species covered\r\ninclude bovine, ovine and caprine tissue (porcine tissue is not included).\r\n\r\n', 'Commission Directive Avril 2003 animal origin.pdf '); INSERT INTO `last` (`news_id`, `quand`, `titre`, `description`, `adresse`) VALUES (11, '2003-09-12', 'EU DIRECTIVES: Consolidated texts', 'Do not forget to maintain in your Quality System the consolidated version updated with last amendments of the EU directives which apply to you (MD, AIMD, IVD).\r\nGo to the section \\"Documents\\" for download.', 'NONE'); INSERT INTO `last` (`news_id`, `quand`, `titre`, `description`, `adresse`) VALUES (12, '2003-12-03', 'Classification of the trials for orthopaedic implants', 'The trials for orthopaedic implants were primarily considered as reusable surgical instrument and classified as Class 1 according to rule 6, second indent of the Annex IX of the Directive 93/42/EEC.\r\n\r\nHowever, considering that these devices did not exactly answer to the definition of Reusable surgical instruments :\r\n“ instrument intended for surgical use by cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures”\r\n\r\nthe \\"Trial hip prosthesis heads or stems\\" were included for the first time in the MEDDEV 2.4/1 rev. 6 of December 99 as examples for class IIa surgically invasive devices according to rule 6.”\r\n \r\nDue to different interpretations of some Notified Bodies, MediMark Europe has questioned the German and the French Competent Authorities to know their position.\r\n\r\nThe German C.A. has confirmed the status of Class 2a for the trial hip prosthesis heads or stems and the French CA has considered that the trial prosthesis in general are in Class 2a.\r\n\r\n\r\nGo to the section “Members” for downloading the full CA answers. \r\n', 'NONE'); INSERT INTO `last` (`news_id`, `quand`, `titre`, `description`, `adresse`) VALUES (13, '2004-02-27', 'New European Guidelines for Animal Tissues', 'Further to the New Directive 2003_32_EC for Medical Devices utilising tissues or derivatives originating from animals for which a TSE risk is suspected, the European Commission has just published a guide for Manufacturers and Notified Bodies : MEDDEV. 2.11_1 rev. 1. Download here the text in pdf and its Annex 1 in word', 'MEDDEV_2_11_1 rev1 Animal tissues.pdf'); INSERT INTO `last` (`news_id`, `quand`, `titre`, `description`, `adresse`) VALUES (14, '2004-02-27', 'Guide Animal Tissue Annex 1', '', 'MEDDEV_2_11_1 rev1 Animal tissues Annex 1.doc'); INSERT INTO `last` (`news_id`, `quand`, `titre`, `description`, `adresse`) VALUES (15, '2004-02-27', 'New Guide for Medical devices containing Natural Rubber latex', 'the European Commission has just published a guide for Manufacturers and Notified Bodies concerning the implications of the Medical Devices containing Natural Rubber Latex', 'MEDDEV_2_5_9_rev1 MD with Latex.pdf'); INSERT INTO `last` (`news_id`, `quand`, `titre`, `description`, `adresse`) VALUES (16, '2004-04-27', 'Status of Orthopaedic Implants under Directive 93/42/EEC ', 'The European Medical Devices Expert Group (MEDG) Task Force on\r\nReclassification considered a Proposal from Competent Authorities in June\r\n2003 that joint replacement implants should be reclassified as from Class\r\nIIb to Class III. The European Commission has recently also consulted on a\r\ndraft Directive on the reclassification of joint implants. It is\r\nanticipated that this Directive could be adopted as early as May 2004. Once\r\nthe Directive comes into effect it is proposed that there will be a 2.5\r\nyear transition period for new products and a 2 - 3 year transition period\r\nfor products already certified and on the market. Consequently all joint\r\nreplacement implants will need an EC Design Examination under Annex II\r\nsection 4 (or an EC Type Examination under Annex III).\r\n', ''); INSERT INTO `last` (`news_id`, `quand`, `titre`, `description`, `adresse`) VALUES (17, '2004-05-26', 'WEEE and ROHS Directives', 'The WEEE Directive is to take effect from August 13, 2005 and places an obligation to the producers of electronics to take back "end of life" or waste products free of charge. What is the impact for MD and IVDD manufacturers ?', 'WEEE and ROHS Directives MME Summary.pdf'); INSERT INTO `last` (`news_id`, `quand`, `titre`, `description`, `adresse`) VALUES (18, '2004-12-01', 'NEW FRENCH TAX', 'December 1, 2004 : Deadline for the French Declaration and payment of Tax laid on promotion fees of Reimbursed Medical Devices mentioned in article L.165-1 of the Code de la Sécurité Sociale (National Health Service Code) having been sold in France', 'New French taxe reimbursed medical devices Dec 04.pdf'); INSERT INTO `last` (`news_id`, `quand`, `titre`, `description`, `adresse`) VALUES (19, '2004-12-01', 'NEW FRENCH TAX', '2004 French Declaration Form for reimbursed devices', 'French declaration 2004 for reimbursed devices.pdf'); -- -------------------------------------------------------- -- -- Structure de la table `links` -- DROP TABLE IF EXISTS `links`; CREATE TABLE IF NOT EXISTS `links` ( `links_id` tinyint(4) NOT NULL auto_increment, `nom` varchar(255) NOT NULL default '', `description` varchar(255) NOT NULL default '', `adresse` varchar(255) NOT NULL default '', PRIMARY KEY (`links_id`) ) TYPE=MyISAM AUTO_INCREMENT=23 ; -- -- Contenu de la table `links` -- INSERT INTO `links` (`links_id`, `nom`, `description`, `adresse`) VALUES (1, 'Single Market - New Approach and Global Approach:', 'This site provides information on the New Approach to technical harmonisation and the Global Approach to conformity assessment.', 'http://europa.eu.int/comm/enterprise/newapproach/'); INSERT INTO `links` (`links_id`, `nom`, `description`, `adresse`) VALUES (2, 'MD, IVD, AIMD Directives:', 'This site from the European Commission gives you the integral texts of the Directives and much more.', 'http://europa.eu.int/comm/enterprise/medical_devices/'); INSERT INTO `links` (`links_id`, `nom`, `description`, `adresse`) VALUES (3, 'Guidelines for the MD, IVD, AIMD Directives:', 'You will find the updated “MEDDEV” guidance document from the European Commission concerning the vigilance system, classification, etc …', 'http://europa.eu.int/comm/enterprise/medical_devices/meddev/index.htm'); INSERT INTO `links` (`links_id`, `nom`, `description`, `adresse`) VALUES (4, 'Harmonized Standards for the IVD Directive.', '', 'http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/invimedd.html'); INSERT INTO `links` (`links_id`, `nom`, `description`, `adresse`) VALUES (5, 'Harmonized Standards for the MD Directive:', '', 'http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html'); INSERT INTO `links` (`links_id`, `nom`, `description`, `adresse`) VALUES (6, 'Useful links and contact points for the Community legal framework.', '', 'http://europa.eu.int/comm/health/index_en.html'); INSERT INTO `links` (`links_id`, `nom`, `description`, `adresse`) VALUES (7, 'List of vigilance contact points within the European Competent Authorities:', '', 'http://europa.eu.int/comm/enterprise/medical_devices/ca/list_ca.htm'); INSERT INTO `links` (`links_id`, `nom`, `description`, `adresse`) VALUES (8, 'Official journal of the European Communities:', '', 'http://www.europa.eu.int/eur-lex/en/oj/index.html'); INSERT INTO `links` (`links_id`, `nom`, `description`, `adresse`) VALUES (9, 'MHRA – Competent Authority for United Kingdom:', '', 'http://www.medical-devices.gov.uk/'); INSERT INTO `links` (`links_id`, `nom`, `description`, `adresse`) VALUES (10, 'French Drug and Medical Agency:', '', 'http://agmed.sante.gouv.fr/'); INSERT INTO `links` (`links_id`, `nom`, `description`, `adresse`) VALUES (11, 'European information system for Medical Devices (EUDAMED)', '', 'http://www.dimdi.de'); INSERT INTO `links` (`links_id`, `nom`, `description`, `adresse`) VALUES (12, 'Standards:', 'Looking for British, European or international standards? British Standards Online is the exclusive, authoritative, and most current site for all publications from BSI.', 'http://bsonline.techindex.co.uk/BSI2/Dir1/sitepage.asp?LS=&PgID=0000&LR=&LD=&Src=&Dest=&Last=&SessID=XXDWKN19RREL8N1BLVNK21J23LAHDJQB&MSCSID=&ErrID=&SessStat=&Parent=&Child=&PCount=0&LogStat=&URLData='); INSERT INTO `links` (`links_id`, `nom`, `description`, `adresse`) VALUES (20, 'Recommendation documents relative to the Medical Directives', 'The Recommendations \\"NB-MED\\" are issued by the European association of Notified Bodies for Medical Devices (including IVD''s). They translate the Directive requirements in practical guidelines and take positions concerning some grey areas.', 'http://www.eanbmed.org/'); INSERT INTO `links` (`links_id`, `nom`, `description`, `adresse`) VALUES (16, 'Consulting and Organization of Clinical trials in Europe', ' \r\n', 'http://www.medalliance.org'); INSERT INTO `links` (`links_id`, `nom`, `description`, `adresse`) VALUES (17, 'Strategic Planning, Regulatory Submissions, Manufacturing Compliance, or Quality Systems and Representation before the US FDA and HPB Canada:', 'International Regulatory Consulting:', 'http://www.intregcon.com'); INSERT INTO `links` (`links_id`, `nom`, `description`, `adresse`) VALUES (18, 'GLOBAL LANGUAGE SOLUTIONS:', 'Translation agency with offices in California, USA. Expertise in multilingual translation of medical and pharmaceutical documents - clinical trial reports, IFUs, MSDS, drug labels, corporate press releases, and much more.', 'http://www.globallanguages.com'); INSERT INTO `links` (`links_id`, `nom`, `description`, `adresse`) VALUES (21, 'Biomedical Translations', 'Translation Experts for your In-Vitro Diagnostic Devices and Medical Devices.', 'http://www.biomedical.com'); INSERT INTO `links` (`links_id`, `nom`, `description`, `adresse`) VALUES (22, 'EDMS for IVD''s CODIFICATION', 'EDMS Nomenclature issued by EDMA is used for the notification of IVD Medical Devices to European Competent Authorities', 'http://www.edma-ivd.be/Classification/Final_version_5.xls'); -- -------------------------------------------------------- -- -- Structure de la table `members` -- DROP TABLE IF EXISTS `members`; CREATE TABLE IF NOT EXISTS `members` ( `member_id` tinyint(4) NOT NULL auto_increment, `name` varchar(20) NOT NULL default '', `login` varchar(20) NOT NULL default '', `adresse` varchar(255) NOT NULL default '', `niveau` enum('visitor','member') NOT NULL default 'visitor', PRIMARY KEY (`member_id`) ) TYPE=MyISAM AUTO_INCREMENT=112 ; -- -- Contenu de la table `members` -- INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (74, 'Francis Powell', 'newma70', 'fpowell@newmarkinc.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (11, 'Bill Elesh', 'medov21', 'belesh@medovations.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (12, 'Lynette Howard', 'medim03', 'LYLEHOWARD@aol.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (13, 'Rene Clement', 'medim02', 'r.clement@medimark-europe.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (14, 'Philippe Leglise', 'medim02', 'p.leglise@medimark-europe.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (15, 'Christine Terrier', 'medim04', 'c.terrier@medimark-europe.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (19, 'Susan Horne', 'exact13', 'Susan.Horne@exac.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (20, 'Eben Gordon', 'endoc63', 'egordon@endocare.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (21, 'Robyn Smyth', 'agen101', 'robyn@agen.com.au', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (22, 'Ann Ellerman', 'agen101', 'ANN@agen.com.au', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (25, 'David Lang', 'lang18', 'dlang@langdental.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (26, 'Laura Singer', 'massi20', 'laura@massie-labs.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (28, 'Brad Amundson', 'Brad', 'Brad_Amundson@sgs.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (95, 'Richard Lam', 'GAC014', 'rlam1@gacintl.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (30, 'Mike Webb', 'calm09', 'mwebb@calmedlab.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (31, 'Doug Crumb', 'dhd011', 'DougC@dhd.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (72, 'Danette Than', 'mbl104', 'qsrcompl@mbl2000.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (34, 'Jeanette Zerella', 'GAC014', 'jzerella1@gacintl.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (103, 'Carl Wortham', 'RHEIN34', 'c.wortham@rheinmedical.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (36, 'Paul Garant', 'nmt068', 'pag@nmtmedical.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (37, 'Nicole Brouillette', 'mira025', 'qara@mirainc.net', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (38, 'Lee Fuller', 'full112', 'lee@fullerlabs.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (102, 'Vikram Verma', 'MIRA25', 'qara@mirainc.net', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (40, 'Harald Ceschinski', 'MTI024', 'Ceschinski@dendron.org', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (41, 'Wayne Emmert', 'STAT38', 'WEmmert@Statcorp.net', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (42, 'Carol Thompson', 'SLI108', 'CThompson@streck.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (43, 'Manon AUDET', 'MDC113', 'ma@medicorp.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (44, 'Ed Boehmer', 'ACUM02', 'eboehmer@accumed.net', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (46, 'Mark Stavro', 'aname57', 'marks@anamedinc.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (47, 'Michael Andrews', 'anima53', 'michaeland@animascorp.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (48, 'AVOTEC', 'avotec04', 'paul@avotec.org', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (49, 'Larry Kludt', 'ballar01', 'lrkludt@kcc.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (50, 'Debbie Petit', 'bbi107', 'dpetit@bbii.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (51, 'Chris Serocke', 'biolu55', 'cserocke@biolucent.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (101, 'Missy Squires', 'innom46', 'missy@innomed.net', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (100, 'Missy Squires', 'innom46', 'missy@innomed.net', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (54, 'Lindsay Witmer', 'dhd11', 'lindsayw@dhd.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (55, 'Tracey Kirsch', 'epii58', 'tracey@epii.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (56, 'Rich Ferrick', 'empha59', 'rferrick@emphasysmedical.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (57, 'Dennis DeVona', 'endo51', 'endocraft1@aol.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (58, 'Mike Winegar', 'ev324', 'mwinegar@ev3.net', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (60, 'Karen Norman', 'exact13', 'karen.norman@exac.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (61, 'Suzon Lommel', 'foxho61', 'slommel@foxhollowtech.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (62, 'Jeff Fleishman', 'immun111', 'jfleishman@immunostics.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (63, 'Marci Halevi', 'imple48', 'marci.halevi@implex.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (64, 'Steve Reitzler', 'inner56', 'stevenr@innercool.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (65, 'Sally McClelland', 'innom46', 'smcclelland@innomed.net', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (66, 'Patrick Balsman', 'jas52', 'patrick@bonuttiresearch.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (67, 'Marguerite Demeter', 'kinam17', 'mdemeter@kinamed.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (68, 'Joanne lang', 'lang18', 'jlang@langdental.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (69, 'Bert Massie', 'massi20', 'bmassie@retcam.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (70, 'Don Deyo', 'pacea54', 'don.deyo@medtronic.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (71, 'Chris Spofford', 'micro72', 'chriss@microaire.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (75, 'Robert McAndrew', 'opdop26', 'bob@opdop.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (76, 'David McIlhenny', 'ortho50', 'dmcilhenny@orthovita.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (99, 'Sheryl Higgins', 'biolu55', 'shiggins@biolucent.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (78, 'Carl Stubbings', 'panbi103', 'carl_stubbings@panbio.com.au', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (79, 'Kim Servance', 'abbott27', 'kimsmith-servance@abbott.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (80, 'Sandra Kristensen', 'pst29', 'sandyk@bcm.net', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (81, 'Mark Grossman', 'precis32', 'mark@precisiondental.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (82, 'Bill Fichtel', 'poci30', 'quality@poci.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (83, 'Tom Wiliiams', 'cooper33', 'tom.williams@coopersurgical.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (84, 'sandy Koralewski', 'pulmon71', 'Skoralewski@pulmonetic.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (85, 'Don Wiggins', 'rhein34', 'd.wiggins@rheinmedical.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (86, 'Tom Hall', 'safety60', 'thall@safetysyringes.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (87, 'Dan Miller', 'subq37', 'dmiller@subqinc.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (88, 'Rachel Hall', 'tcimed64', 'rhall@tcimed.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (89, 'Michelle Padgett', 'thera39', 'mpadget@knitrite.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (90, 'Melita Lambiris', 'thermo109', 'melita.lambaris@thermotrace.com.au', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (91, 'Don ertl', 'vital42', 'dertl@vitalimages.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (92, 'Gary Lamoureux', 'wwmed44', 'gary@wwmedtech.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (94, 'Gary Snow', 'rubic73', 'gsnow@rubiconmed.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (96, 'Erv Heider', 'poci30', 'eheider@poci.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (97, 'Sherry L. Strickland', 'nemon75', 'sstrickland@nemon.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (98, 'GIZEM', 'BCK045', 'gtanrikilici@bicakcilar.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (104, 'Doug Johnson', 'NEWMA70', 'djohnson@newcare.net', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (105, 'Christine Brown Stry', 'pacea54', 'christine.brown.strysik@medtronic.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (106, 'Darlene Deptula', 'oni74', 'd.deptula@onicorp.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (107, 'Doug Woodruff', 'anima53', 'Doug.Woodruff@animascorp.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (109, 'Lisa Simpson', 'exact13', 'Lisa.simpson@exac.com', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (110, 'Alan Edgecomb', 'imped76', 'aedgecomb@impedimed.', 'member'); INSERT INTO `members` (`member_id`, `name`, `login`, `adresse`, `niveau`) VALUES (111, 'Greg Sprehn', 'massie20', 'gsprehn@massie-labs.com', 'member'); -- -------------------------------------------------------- -- -- Structure de la table `mme` -- DROP TABLE IF EXISTS `mme`; CREATE TABLE IF NOT EXISTS `mme` ( `mme_id` tinyint(4) NOT NULL auto_increment, `titre` varchar(50) NOT NULL default '', `description` mediumtext NOT NULL, `lien1` varchar(255) NOT NULL default '', `lien2` varchar(255) NOT NULL default '', PRIMARY KEY (`mme_id`) ) TYPE=MyISAM AUTO_INCREMENT=23 ; -- -- Contenu de la table `mme` -- INSERT INTO `mme` (`mme_id`, `titre`, `description`, `lien1`, `lien2`) VALUES (14, 'MEDIMARK VIGILANCE PROCEDURES', 'RECALL', 'Recall Process pg08 Rev3.pdf', 'Recall Notification Report Form _ recnot rev02 PG08 Annex 3.pdf'); INSERT INTO `mme` (`mme_id`, `titre`, `description`, `lien1`, `lien2`) VALUES (15, 'MEDIMARK VIGILANCE PROCEDURES', 'RECALL Continued : Model of recall letter to European distributors', 'recdistr rev02 PG08 annex 1.pdf', ''); INSERT INTO `mme` (`mme_id`, `titre`, `description`, `lien1`, `lien2`) VALUES (16, 'MEDIMARK EUROPE ISO 9001:2000 Certificate', '', 'MediMark ISO 9001_2000 Certificate.jpg', ''); INSERT INTO `mme` (`mme_id`, `titre`, `description`, `lien1`, `lien2`) VALUES (17, 'SYMBOLS FOR LABELS', 'COMPILATION OF SYMBOLS USED IN THE \r\nMEDICAL DEVICE INDUSTRY ENVIRONMENT\r\nPART I : MD & IVD Specific Symbols\r\nPART II : General Safety and other purpose Symbols which may be useful to IVD and MD Manufacturers \r\nPART III : CE mark Symbol', 'MME Symbol Word_oct2003.doc', ''); INSERT INTO `mme` (`mme_id`, `titre`, `description`, `lien1`, `lien2`) VALUES (13, 'MEDIMARK VIGILANCE PROCEDURES', 'FINAL REPORT', 'Final Incident reporting Process pg07 Rev2.pdf', 'Final Incident Reporting Form MTVFIN rev3.pdf'); INSERT INTO `mme` (`mme_id`, `titre`, `description`, `lien1`, `lien2`) VALUES (4, 'Confidential Last News:', ' Package sent to our clients for the 2003 French Tax Declaration. \r\n Monthly Exchange Rates between US $ and Euros for year 2002', '2003_FRENCH_TAX_PACKAGE.pdf', ''); INSERT INTO `mme` (`mme_id`, `titre`, `description`, `lien1`, `lien2`) VALUES (5, 'MediMark Europe Biblio', 'Documents kept at your disposal for consultation or copy when permitted \r\n', 'BIBLIO_update_03_09_2003_EN.pdf', ''); INSERT INTO `mme` (`mme_id`, `titre`, `description`, `lien1`, `lien2`) VALUES (12, 'MEDIMARK VIGILANCE PROCEDURES', 'INITIAL REPORT', 'Initial Incident reporting Process pg06 Rev2.pdf', 'Initial Incident Reporting Form MTVINI rev3.pdf'); INSERT INTO `mme` (`mme_id`, `titre`, `description`, `lien1`, `lien2`) VALUES (6, '', '', '', ''); INSERT INTO `mme` (`mme_id`, `titre`, `description`, `lien1`, `lien2`) VALUES (7, 'Labels of IVD reagents', 'Overview of the Labels requirements for IVD reagents in Europe. EDMA Guidance Document, 28 February 2002', 'EDMA_GUIDANCE_Labels_feb02.pdf', ''); INSERT INTO `mme` (`mme_id`, `titre`, `description`, `lien1`, `lien2`) VALUES (8, 'EDMA Symbols for IVD reagents/components.', 'EDMA, the European Diagnostic Manufacturers Association, proposes to the IVD manufacturers a number of Industry Symbols', 'EDMA_Symbols_Revision_Feb02.pdf', ''); INSERT INTO `mme` (`mme_id`, `titre`, `description`, `lien1`, `lien2`) VALUES (9, 'User Awareness of Symbols. September 2002', 'Multilingual translation of Symbols. EDMA Guidance Document.', 'EDMA_GUIDANCE_User_Awareness_Translation_final.pdf', ''); INSERT INTO `mme` (`mme_id`, `titre`, `description`, `lien1`, `lien2`) VALUES (10, 'European Languages for IVD''s', 'Approach on Languages which may be requested by Member States. April 2003', 'langues IVD 2003.pdf', ''); INSERT INTO `mme` (`mme_id`, `titre`, `description`, `lien1`, `lien2`) VALUES (11, 'MEDIMARK VIGILANCE PROCEDURES', ' This section gives you the ISO certified procedures and forms that Medimark Europe utilizes for analysis and reporting adverse events and recalls. You may add these :\r\nprocedures in your Technical File / documentation and include them in your own quality system \r\n\r\nSEE the sub-sections of MediMark Vigilance procedures for download', '', ''); INSERT INTO `mme` (`mme_id`, `titre`, `description`, `lien1`, `lien2`) VALUES (18, 'MEDIMARK VIGILANCE PROCEDURES', 'Assessment of incidents / adverse events to determine the reportability to Competent Authorities', 'Incident Analysis Process pg05 Rev2.pdf', 'Assessment Report for Incident Classification pg05 _ MTVCLAS Rev4.pdf'); INSERT INTO `mme` (`mme_id`, `titre`, `description`, `lien1`, `lien2`) VALUES (19, 'Orthopaedic trials Classification', 'The trials for orthopaedic implants were primarily considered as reusable surgical instrument and classified as Class 1 according to rule 6, second indent of the Annex IX of the Directive 93/42/EEC.\r\n\r\nHowever, considering that these devices did not exactly answer to the definition of Reusable surgical instruments :\r\n“ instrument intended for surgical use by cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures”\r\n\r\nthe \\\\\\"Trial hip prosthesis heads or stems\\\\\\" were included for the first time in the MEDDEV 2.4/1 rev. 6 of December 99 as examples for class IIa surgically invasive devices according to rule 6.”\r\n \r\nDue to different interpretations of some Notified Bodies, MediMark Europe has questioned the German and the French Competent Authorities to know their position.\r\n\r\nThe German C.A. has confirmed the status of Class 2a for the trial hip prosthesis heads or stems and the French CA has considered that the trial prosthesis in general are in Class 2a.\r\n', 'Trial prosthesis Classification.pdf', ''); INSERT INTO `mme` (`mme_id`, `titre`, `description`, `lien1`, `lien2`) VALUES (20, 'The Ten New European Member States', 'On May 1st 2004, ten new countries of Eastern and central Europe have joined the European Union. The MD, AIMD and IVD Directives ought to be transposed at this date. However most of the new entrants are late in the transposition or have published national legislations which are not in line with the Directives. We give you a summary of the situation for each country with also language requirements.', 'CENTRAL EASTERN_EUROPE Avril 2004.doc', 'Directive Transposition New Europe April 4 2004.doc'); INSERT INTO `mme` (`mme_id`, `titre`, `description`, `lien1`, `lien2`) VALUES (21, 'EUROPEAN LAWYER LIST', 'Isabelle Lucas-Baloup, the well known French lawyer specialized in defending MD & IVD Manufacturers has given to MediMark Europe for you the list of her correspondents in the main European countries.', 'EUROPEAN LAWYER LIST.doc', ''); INSERT INTO `mme` (`mme_id`, `titre`, `description`, `lien1`, `lien2`) VALUES (22, 'RoHS Directive. July 7 2004.', 'Eucomed Response to RoHS Public Consultation.\r\nExemption for Medical technology should remain.', 'EUCOMED POSITION ON ROHS DIRECTIVE July 7 2004.pdf', ''); -- -------------------------------------------------------- -- -- Structure de la table `mme_news` -- DROP TABLE IF EXISTS `mme_news`; CREATE TABLE IF NOT EXISTS `mme_news` ( `mme_id` tinyint(4) NOT NULL auto_increment, `mme_date` date NOT NULL default '0000-00-00', `titre1` varchar(60) NOT NULL default '', `titre2` varchar(60) NOT NULL default '', `titre3` varchar(60) NOT NULL default '', `titre4` varchar(60) NOT NULL default '', `titre5` varchar(60) NOT NULL default '', `titre6` varchar(60) NOT NULL default '0', `lien` varchar(255) NOT NULL default '', PRIMARY KEY (`mme_id`) ) TYPE=MyISAM AUTO_INCREMENT=12 ; -- -- Contenu de la table `mme_news` -- INSERT INTO `mme_news` (`mme_id`, `mme_date`, `titre1`, `titre2`, `titre3`, `titre4`, `titre5`, `titre6`, `lien`) VALUES (1, '2001-01-01', 'Symbols for IVD and MD product labels', '', '', '', '', '', '01_2001.pdf'); INSERT INTO `mme_news` (`mme_id`, `mme_date`, `titre1`, `titre2`, `titre3`, `titre4`, `titre5`, `titre6`, `lien`) VALUES (2, '2000-12-01', 'Special Sterilization : ISO-14937', '', '', '', '', '', '2000_12_01.htm'); INSERT INTO `mme_news` (`mme_id`, `mme_date`, `titre1`, `titre2`, `titre3`, `titre4`, `titre5`, `titre6`, `lien`) VALUES (3, '2000-01-01', 'Label and IFU for IVD Products, Applicable standards', 'Languages per country, Notification', 'Miscellaneous', '', '', '', '2000_01_01.htm'); INSERT INTO `mme_news` (`mme_id`, `mme_date`, `titre1`, `titre2`, `titre3`, `titre4`, `titre5`, `titre6`, `lien`) VALUES (4, '1999-06-01', 'ISO 9001: 2000, Risks Analysis', 'The Metric Directive', '', '', '', '', '1999_06_20.htm'); INSERT INTO `mme_news` (`mme_id`, `mme_date`, `titre1`, `titre2`, `titre3`, `titre4`, `titre5`, `titre6`, `lien`) VALUES (5, '1999-01-01', 'Status on Non-CA Marked products', 'Future ISO 9000', 'EUDAMED, Miscellaneous', '', '', '', '1999_01_19.htm'); INSERT INTO `mme_news` (`mme_id`, `mme_date`, `titre1`, `titre2`, `titre3`, `titre4`, `titre5`, `titre6`, `lien`) VALUES (6, '2001-07-01', 'IVD Directive 98/79/EC', 'Registration of manufacturers and devices ...', 'Potential taxes to be paid ...', '', '', '', 'MMENEWS07-2001_revUS2.doc'); INSERT INTO `mme_news` (`mme_id`, `mme_date`, `titre1`, `titre2`, `titre3`, `titre4`, `titre5`, `titre6`, `lien`) VALUES (7, '2002-02-02', 'IVD''s and MD''s Recall', 'What shall you do when implementing a recall in Europe', 'Global Harmonization Task Force', '', '', '', 'MMENEWS 02_2002 Final.doc'); INSERT INTO `mme_news` (`mme_id`, `mme_date`, `titre1`, `titre2`, `titre3`, `titre4`, `titre5`, `titre6`, `lien`) VALUES (9, '2002-07-31', 'IVDs : European Registration', 'List of European Competent Authorities for IVDs', 'When shipping devices after CE Marking', '', '', '', 'MMENEWS 07_2002.pdf'); INSERT INTO `mme_news` (`mme_id`, `mme_date`, `titre1`, `titre2`, `titre3`, `titre4`, `titre5`, `titre6`, `lien`) VALUES (11, '2003-02-26', 'Expanding E.U. in May 2004', 'CE Marked devices for 28 European countries', 'The last changes in European Regulatory Affairs', '', '', '', 'MMENEWS02_2003 USA rev 2.pdf');