Senior Vice President Global Medical Devices, BSI Group
Pharmaceutical Industry 1981 -1994
Novartis AG /Merck Inc./Purdue Frederick Inc.
Medical Device Manufacturing Industry 1994 – 2008
10 years Medtronic:
National Sales Manager Interventional Cardiology
Sales Director Cardiac Rhythm Management (UK)
General Manager Vitatron UK & Ireland (Medtronic Group Company)
3 years Boston Scientific:
Business Unit Director Cardiac Rhythm Management (UK & Ireland)
BSI Group 2008 to Date
Business UNIT Director Medical Devices: With responsibility for all EU Notified Body activity including: Manufacturing Site Audit & Assessment, Product Certification to meet EU Medical Device directives (CE) and all Medical Device Certification Approval Body (CAB) activities globally.
Senior Vice President – Global Medical Devices and Life sciences (Washington DC USA). Full P&L responsibility for all EU Notified Body activity including: Manufacturing Site Audit & Assessment, Product Certification and all other Global Medical Devices CAB services.
Senior Vice President – Global Medical Devices –Relocated back to the UK
2 blogs from the author
Posted on 14.09.2018
What does Brexit mean for Notified Bodies?
With 45% of devices accessing the EU via UK NBs, what would be the impact of a so-called “hard Brexit?” The political landscape is far from clear. However, BSI would concur with the recent MHRA paper as we fully anticipate remaining part of the EU system for the long term. We also agree that nothing […]
Posted on 12.09.2018
New EU regulations: what’s next for Notified Bodies?
It is now circa ten months since any well-prepared Notified Bodies (NB) wishing to undertake conformity assessment under MDR (EU) 2017/745 and IVDR (EU) 2017/746 were able to submit formal applications. The date of application of the MDR and IVDR, 27th May 2020, is currently 20 months away. I would like to publicly acknowledge the […]