Reviewers Experience & Qualifications

Bernard Tremaine is the Lead Reviewer

Bernard’s main areas of accomplishment during the last 20 years of his career include;

Had a Client base of over 100 USA medical device manufacturers, for whom he provided Authorised Representative Services. This facilitated their compliance with the EU CE Marking regulations (MDD 93/42/EEC as amended by 2007/47/EC) and enabled  marketing of their product range in the European Community. 


• Helped scores of manufacturers (from single person entities through to Multinational global names (eg: Boots Nottingham) to implement ISO 13485 type Quality Systems, as part of their CE Marking strategy. 


• Was an active member of ABHI (Association of British Healthcare Industries) for several years.


Audited  several hundred  medical device manufacturers, located in Europe, North America, the Middle East and Asia, for all classes of device, on behalf of UK Notified Bodies, for CE Marking compliance.


•  Many 1000’s of hours of auditing experience, covering Class IS-M / IIa / IIb / III devices (Sterile, non-sterile, Diagnostic, Therapeutic, Implantable, etc etc), as the Lead Auditor or a Support Auditor, on behalf of UK Notified Bodies.  


• Conducted many 100’s of Desktop reviews of Technical Files, Design Dossiers and Design Files, for medical device manufacturers, on behalf of UK Notified Bodies.


• In particular, a manufacturers compliance with the Clinical Evaluation Data, Risk  Management process and Post Market Feedback requirements were paramount. 


• Has provided Advice and Consultancy to numerous single person upwards SME Companies to accomplish any aspect of Regulatory Compliance for any Class (I / IIa / IIb / III) of General Medical Device or IVD (In Vitro Diagnostic) Medical Device. 

Bernard's CV

An abbreviated copy of Bernard's CV is available here.


A copy of his Full CV is available upon request.

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Medical Device Regulatory Solutions

MDRS-EU, ALTRINCHAM, Cheshire WA15 7SN, GB

Email: bjst1945@gmail.com / Tel: +44 (0) 161 870 6751