Bernard's Summary CV...

SUMMARY CV

  

Summary of Bernard Tremaine’s career.


2015 August – Present Providing Ad hoc Consultancy and Medical Device strategy solutions on an informal basis. www.mdrs-eu.uk 


1994 – August 2015  Owner, Managing Director & CEO of MDQAS Ltd. www.mdqaconsultancy.co.uk/ 


❶ Provision of Authorised Representative Services and associated CE Marking Regulatory Solutions. 


❷ European Notified Body (NB) Lead Auditor for medical device manufacturers.


❸ European Notified Body, Technical File & Design Dossier reviewer.


● Contributing author to Eucomed “Guide to implementing European Regulations”.


● Proof reading of Medical Device Labelling and associated Literature.


1990 – 1994 Manager, European Regulatory Affairs – Marquette Electronics Inc, Mil. WI. USA.

Wide range of Multi-Parameter Patient Monitoring systems, Active Therapeutic and Diagnostic Medical Devices.


1975 – 1990 European Service Manager - Marquette Electronics Inc, Milwaukee. WI. USA.

Wide range of Multi-Parameter Patient Monitoring systems, Active Therapeutic and Diagnostic Medical Devices.

Specifically:

Multi-parameter Patient Monitoring Systems; eg: ITU/ICU/HDU/CCU/etc 


Automated Analysis of 12 Lead ECG data (MUSE);


Holter Monitoring Systems;


Catheterization Lab Systems.


1970 – 1975 Service Manager, North of EnglandSimonsen & Weel, Denmark

Range of Patient Monitoring and Active Diagnostic Medical Devices.


1960 – 1970 Various positions within Colour Television manufacturing (Baird TV, Bradford, Yorkshire);

Various positions in National Television Rental companies; (Radio Rentals; Granada; etc etc).


Summary CV with additional summary data: www.mdrs-eu.uk/experience 


My full CV is available upon request. 


Explanation of dealings with USA Medical Device Manufacturers;


❶ MDQAS Ltd provided Authorized Representative Services to over 100 USA manufactures who sold their Devices into the 30+ countries of the European Union, EEA and EFTA market.

In addition, Bernard provided Consultancy to assist manufacturers to accomplish Regulatory Strategies to CE Mark Class I(S+M); Class IIa; Class IIb and Class III medical devices, including Own Brand Labelling strategies (now Virtual Manufacturing).


❷ Bernard has well in excess of 4,000 hours’ experience, auditing scores of USA Device manufacturers, on behalf of European Notified Bodies, for compliance with directive 93/42/EEC (medical device directive) as amended by 2007/47/EC, including ISO 13485 / ISO 9001 QMS’s.


❸ Bernard has many 100’s of hours experience reviewing Technical Files and Design Dossiers, on behalf of UK Notified Bodies. These Technical Documentation reviews focused in the main part in reviewing Clinical Evaluation Data, Risk Management Data & Design Control Data, as part of the compliance documentation.