Regulatory Affairs/Quality Assurance (RA/QA) Engineer for medical devices
2 years experience in Medical Devices
Over 30 years experience in Active Implantable Medical Devices (Class III AIMDs)
Standardisation commitees member
AIMD Expert and Adviser
Over 30 years of experience in Medical Devices
PRRC and Program Manager EMERGO by UL
11 years as inspector - The Netherlands Competent Authority
The Advisory Board
Denys DURAND-VIEL
Corinne DELORME
David R RUTLEDGE
Entire career in medical devices
Auditor for german notified bodies
President of DM Experts
Involved in the implementation of EU and other countries regulations
Head of GMED notified body for >15 years
Regulatory Intelligence Director of NEXIALIST
More than 25 years experience
Leading international regulatory submission
President at Global Strategic Solution LLC in USA
Daniel PETIT
Founder member
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
The Representative PRRC
René DROST
for The Netherlands
Anna AMICH
for Spain
Piero COSTA
for Italy
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
20 years of experience in Pharmacovigilance and Medical Device Post-Market Surveillance and Vigilance
Deputy QPPV and PRRC officer at Novartis
BSc in Pharmacy and Biochemistry, MS in Clinical trials Monitoring, PG Certificate in Epidemiology.
+ 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
José MALTA
for Portugal
Carole ROBIN
for France
Raje MARIKKANNU
for Sweden
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
Over 30 years of experience in Medical Devices (Regulatory, Quality), and 20 years in Clinical Research (international clinical investigations - Competent authority inspection (ANSM) and Clinical Investigations Auditor (MDR and ISO 14155))
PRRC for Manufacturers
PharmD, MS in Quality
+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
Sandra FERRETTI
for Belgium
Christopher KIPP
for Germany
Eric KLASEN
for Switzerland
+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
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
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
The Contributors for Position Papers
Emile UNK
Nadine ADIA
MSc in Criminal Justice & Public Security
Experience & knowledge of Regulatory affairs in various fields
PRRC for an EAR company
PharmD /+ 10 years of experience in Pharmaceutical and medical device
Regulatory affairs Director and PRRC for manufacturer
