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EXPERT WITNESS: Bernard Tremaine's 30+ years in the Healthcare Industry enable Bernard to provide Expert Witness testimony on cases involving medical equipment safety. To discuss any issues in total confidence, please e-mail with your Contact name + telephone details and Bernard Tremaine will call you back to discuss how he might help you. ORIGIN: Medical Device & QA Consultancy was formed in 1994, to assist Manufacturers of Medical Devices to accomplish their European and/or FDA Regulatory compliance. Through arrangements with our Associate Partners, both in the USA and Europe, we are able to offer a truly all-encompassing Service to the Medical Device Manufacturing Industry . DESIGN DOSSIER REVIEWS: Bernard Tremaine also has substantial experience in Reviewing Design Dossiers of Active Medical Devices, on behalf of European Notified Bodies, to assess compliance with the Design Control requirements of Annex II Clause 4 of the Medical Device Directive 93/42/EEC. SERVICES INCLUDE: All aspects of Setting up, Implementing and Improving Quality Systems, including ISO 9001:2008; ISO 13485:2003; and compliance with all Annexes the medical device directive 93/42/EEC as amended by 2007/47/EC (mandatory March 2010) Updating of Quality System s that met the now obsolete EN ISO 13485:2001; ISO 13485:1996 and EN 46001:1996 .
Help can also include a
ranging Notified Body Inspections, FDA 510(k), PMA or IDE Submissions
Process Validation and Qualification;
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PERSONAL PROFILE:
The principle Consultant is Bernard J. Tremaine, who has in excess of 30 years experience in the Health Care industry, encompassing all aspects of Design / Development, Production and Post Sales Support of a wide range of both Active and Non-Active Medical Devices.
Bernard’s last position, prior to forming Medical Device & QA Consultancy, was the Manager of European Regulatory Affairs, for Marquette Electronics Inc in Milwaukee, Wisconsin USA. He held this position from 1990 until 1994.
With a wide experience of Active Device Approvals, having worked directly with all the main Type Testing agencies of Western, Central and Eastern Europe, we can offer Client Companies a choice of all the
Quality System Conformance
routes of Annex II, V or VI
, Annex VII for Class I Devices, along with the EC Type Testing conformance route of Annexes III and IV, and help to ensure a successful Compliance Strategy. TRACK RECORD: Medical Device & QA Consultancy has helped a substantial number of Companies successfully complete their "CE Marking" Strategies, and Bernard Tremaine has well over 4,000 hours experience of Auditing Medical Device Manufacturing Companies for their compliance with the Medical Device Directive, on behalf of European Notified Bodies. These Notified Bodies include; AMTAC # 0437 BVQI # 0301 NQA # 0577 URSIL # 0646 INTERTEK # 0413 ...who were notified under the medical device directive 93/42/EEC PROFESSIONAL MEMBERSHIP:
IRCA - Registered Lead Auditor (Reg No.A007435)
(International Register of Certified Auditors)
(Jan 1994 through Feb 1997) (Association of British Health-Care Industries)
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AUTHORIZED REPRESENTATIVE PROFILE:
We have provided Authorized Representative Services continuously since 1996, to a wide range of Medical Device Manufacturers. These Companies are mainly located in the USA and Canada, but we also represent Manufacturers in the Middle East, the Far East and Australia.
Thereby, we provide a truly Global Authorized Representative service.
We are a small Company, but as a result, we are able to offer a friendly personal service at a minimum realistic and fair cost to our Customers. Recently, in order to ensure Continuity of our Authorized Representative service and more importantly to ensure rapid response to your queries, we have teamed up with Advena Medical Ltd, in order to double our response capability.
FDA SUBMISSIONS:
In addition to offering Medical Device Directive (93/42/EEC) Quality System strategies to Annexes II, V and VI (Similar to the now obsolete ISO 9000:1994 series + EN 46000:1996), we also offer Consultancy on the implementing the FDA 21 CFR 820 QSR Regulation, including the mandatory Design Control requirements, effective June 1998, and also ISO 13485:2003 Quality System standard which has replaced EN 46001:1996.
Bernard has been involved in the successful completion of several FDA compliance Strategies, including 21 CFR 820 QSR Quality System implementation, Post Sales Issues (Including MDR), Post Market Notification (510(k)), Post Market Approval (PMA) and Investigational Device Exemptions (IDE’s). Please see these two Links for recent successful 510(k) submissions: http://www.accessdata.fda.gov/scripts/
cdrh/cfdocs/cfPMN/pmn.cfm?ID=4334 http://www.accessdata.fda.gov/scripts/
cdrh/cfdocs/cfPMN/pmn.cfm?ID=2892
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