OUR TEAM
The Board
Elem AYNE
President
- PRRC for an Authorised Representative company and Manufacturers
- Regulatory Affairs Consultant at ACR Medical
- Auditor
- > 10 years experience in Industry
Anne JURY
Vice – President
- Regulatory affairs consultant
- Over 25 years experience in the medical and diagnostic healthcare techhnology industries
- Former lead auditor at BSI and TÜV SÜD
Bassil AKRA
Vice – President
- Supporting Medical Device and In-Vitro Diagnostic Industry to get safe, qualitative and well-performing products on the market
- Former vice-president at TÜV SÜD Product Service GmbH
Sandra FERRETTI
Communication & Representative Lead
- +25 years experience in EU Medical Devices regulatory affairs and Cosmetics regulations
- Chief Compliance Officer and Public Affairs Director at Obelis
- Accredited expert in the European Union Medical Device Coordination Group (MDCG)
- Involved in various European Commission working groups
- Recognized international speaker/moderator at seminars and conventions
René DROST
Secretary
- 15 years of experience in Medical Devices, at Hospital level as well as Industry
- Director of NAMCO and FSCA.com
- Secretary of the NL MDR/IVDR Implementation group
- Tutor for Biomedical Engineers and Clinical Perfusionists
Stéphanie DE AGOSTINI
Treasurer
stephanie.de-agostini@team-prrc.com
- + 25 years of experience in Life Sciences-MedTech,
- Industrial background in Pharma, Biotech, Vaccine, Cosmetic, MedTech, and eHealth, supporting small & large companies.
- PRRC and executive leader specialized in Launch excellence approach, organization optimization & innovative solutions management
The Advisory Board
Denys DURAND-VIEL
- Entire career in medical devices
- Former auditor for German notified bodies
- Founder of DM Experts SAS
Corinne DELORME
- Involved in the implementation of EU and other countries regulations
- Head of GMED notified body for >15 years
- Regulatory Intelligence Director of NEXIALIST
David R RUTLEDGE
- Supporting Medical Device and In-Vitro Diagnostic Industry to get safe, qualitative and well-performing products on the market
- Former vice-president at TÜV SÜD Product Service GmbH
The Representative PRRC
Sandra FERRETTI
for Belgium
- +25 years experience in EU Medical Devices regulatory affairs and Cosmetics regulations
- Chief Compliance Officer and Public Affairs Director at Obelis
- Accredited expert in the European Union Medical Device Coordination Group (MDCG)
- Involved in various European Commission working groups
- Recognized international speaker/moderator at seminars and conventions
René DROST
for The Netherlands
- 15 years of experience in Medical Devices, at Hospital level as well as Industry
- Director of NAMCO and FSCA.com
- Secretary of the NL MDR/IVDR Implementation group
- Tutor for Biomedical Engineers and Clinical Perfusionists
Stéphanie DE AGOSTINI
for France
- + 25 years of experience in Life Sciences-MedTech,
- Industrial background in Pharma, Biotech, Vaccine, Cosmetic, MedTech, and eHealth, supporting small & large companies.
- PRRC and executive leader specialized in Launch excellence approach, organization optimization & innovative solutions management
José MALTA
for Portugal
- PharmD | + 15 years of experience in Medical Devices
- PRRC for Manufacturers
- ISO and GxP Auditor
- Associate member of OF – Portuguese Order of Pharmacists and APREFAR – Portuguese Regulatory Affairs Professional Association
- Invited expert designated by APORMED – Portuguese Association of Medical Devices Companies
Carmen MARTIN
for Spain
- CEO & Founder of CMG MEDDEV consultant company in Regulatory, Clinical, and Quality for MD, IVD and MDSW
- + 30 years of experience in quality, regulatory and clinical departments of medical device and IVD manufacturers, SW developers, research centers in genetics, immuno, infectious agents
- Auditor (ISO 15189, 17025 and ISO 13485)
- Outsourced PRRC functions
- Part of the first RAPS (2022) review team for PRRC certification
Ella HELGEMAN
for Denmark
- Pharmacist
- > 10 years experience in MD
- Owner of Serbian company QMS Consulting
- External lead auditor (ISO 13485 & CE marking)
Piero COSTA
for Italy
- + 16 years of experience in Medical Devices
- PRRC and Technical Director
- Vice-President of the BioPmed Cluster
- B.S.I External Tutor for Medical Devices
Michelle KEANE
for Ireland
- Founder & Consultant
Christopher KIPP
for Germany
- Manager Regulatory Affairs at BVMed (Germany medtech association)
- Responsible for working groups PRRC, Labelling, Standards, NB, Supplier and more. Both in the german WG’s and MTE WG’s
Raje MARIKKANNU
for Sweden
- +12 years experience in the MD/IVD industry
- Founder & Consultant – Trinetra Solutions AB
- PRRC for Manufacturers & EAR
- SaMD Expert & Auditor
- RAC Certified from the RAPS, USA
Vladimir BURGIC
for Serbia
- Pharmacist
- > 10 years experience in MD
- Owner of Serbian company QMS Consulting
- External lead auditor (ISO 13485 & CE marking)
Sanna M. MATTILA
for Finland
- Quality & Regulatory Affairs Manager
- > 10 years experience in the pharmaceutical industry and in MD sector
- PRRC for an IVD manufacturer and MD organization
- Served as the chairperson of the MD Regulatory Working Group organized by the Healthtech Finland association from 2017 to 2021, and currently actively participating within this Working Group
Eric KLASEN
for Switzerland
- Consultant in Life Sciences and expert in Regulatory Affairs, QA, and Quality Management Systems
- Board of Directors member of EFGCP, Belgium
- Board of Directors member of SimpliNext, Switzerland
- Advisory Board member of REA Diagnostics, Switzerland
- Supervisory Board member of Diabeter, a group of Diabetes Clinics, the Netherlands
- Chair of the Supervisory Board of NOK, a group of Obesity Clinics, the Netherlands
Jack WALTERS
for UK
- Founder of Sterile Management Systems, a UK-based training and consultancy company, and sister company MediReps in Ireland (AR services)
- Former Notified Body Auditor and technical reviewer with a professional background in material science and microbiology
- QA/RA expertise in MD and related industries
- PRRC services
The Contributors for Position Papers
Emile UNK
- MSc in Criminal Justice & Public Security
- Experience & knowledge of Regulatory affairs in various fields
- PRRC for an EAR company
Nadine ADIA
- PharmD /+ 10 years of experience in Pharmaceutical and medical device
- Regulatory affairs Director and PRRC for manufacturer
- Certified ISO 13485:2016 Internal Auditor (TPECS)
Founder members
Daniel PETIT
- Sales training manager for pharmaceutical manufacturer
- Regional Manager for different MD manufacturers in France (class IIa and IIb)
- Founder and President of a Manager’s MD association
- Former treasurer of TEAM-PRRC
Jean-Louis DIVOUX
- Founder of AIMD
- Former secretary of TEAM-PRRC