Several Nano-Tera projects are tackling medical issues and may need to address medical regulations. As a researcher, it is difficult to know which regulations apply, at what time in the project and how to address them.
As a consequence, Nano-Tera is organizing an information day about these important issues. It will present an overview of the medical regulations (laws, CE Marking, FDA approval, GMP.s, GLP.s, Pre-Clinical Testing, Clinical Evaluation.), notifying bodies and competent authorities (Swissmedic, ethical committees, FDA, TÜV, etc.). It will also help in classifying the research activity according to applicable regulations (well-being, diagnostics, treatment, implants, etc.), and explaining at what time in the project the regulations apply, and how to address them.
The Info Day took place on February 5th, 2015
Introduction Medtech :
- Eucomed stats
- Swiss figures
Terminology - Glossary - Definitions
Regulatory fundamentals :
- Pre market approval systems - USA / FDA
- Conformity assessment system - Europe GHTF / IMDRF
GMP / ISO introduction / GLP PSO
Conformity Assessment Europe
- Clinical evaluation
USA / FDA Pre Market Approval System - PMA, Pre Market Notifcation-510k, Investigational Device Exemption - IDE
Borderline issues - Europe - USA
QSR 21cfr Part 820, ISO 13485
- Good Manufacturing Practices - GMPs,
- Good Laboratory Practices - GLPs
Workshop - GLPs experience (Prof. von Rechenberg, Uni ZH)
Special issues, new technologies - Q&A Session
Pierre-Alain Sommer has 25+ years of experience in the medical devices industry, including R&D, production, distribution, quality and regulatory affairs. After a successful career in Operations, QA & RA of active and non active implantable medical devices, Pierre-Alain has been providing coaching and training services to numerous startups as well as to established industries. Pierre-Alain has also acted more than 10 years as notified body auditor and is an experienced FDA QSR, PMS and 510k expert.
Michael Maier has 15+ years of hand on experience within medical device industry in design & development projects, product industrialization and regulatory & quality affairs. Michael is a trained notified body auditor for ISO 13485 and MDD with a broad scope of products. He has worked for the notified bodies of DEKRA, KEMA and Swiss TS and covered international compliance programs as CMDCAS, J-PAL, TCP, TGA. Michael combines sound technological knowledge with global regulatory expertise in medical devices. Michael holds a MBA in corporate management, a master in Medical Engineering and a Swiss Certificate of Capacity as precision mechanic. Regularly, he is speaker in international events for medical devices, quality and regulatory affairs topics.