Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel)

Standalone Modules

Module 4 - EU Medical Device Regulations Part C

 

Content

Module 4 deals with the stages of the lifecycle of a medical device from submission to discontinuation. It provides participants with the regulatory skills necessary to introduce a medical device to the European market and to effectively monitor and manage its performance. This module also addresses the regulatory considerations and processes involved in implementing post-market changes to medical devices.

Start & Duration

Module 4 starts in April each year. 
The completion takes approximately 10 weeks.

Credits

6 ECTS

Fee

The cost of this standalone module is 6'300.– SFr.

Reference

03.004

 

Module Leaders

Regulatory Affairs Director at Decomplix AG

Helena Lacalle

Helena Lacalle is a Regulatory Affairs professional with 25+ years of experience in strictly regulated industries, mainly medical devices and pharmaceuticals. She holds a pharmacy degree from the University of Barcelona, and a master degree in statistics from the University of Neuchatel, Switzerland. In January 2020, Helena joined Decomplix AG, a regulatory consultancy company that also offers Swiss Authorized Representative (CH-REP) services, where she is the Regulatory Affairs Director and simultaneously acts as Person Responsible for Regulatory Compliance (PRRC) for Decomplix’ CH-REP role.

Founder, Chairman and CEO of confinis ag (Switzerland and USA)

Beat U. Steffen

Beat Steffen, RAC, FRAPS, Founder, Chairman & CEO of confinis ag, (Switzerland and USA) holds a MSc in electrical engineering an executive MBA and has 25+ years of experience in medical device and combination product development/manufacturing/quality management/regulatory affairs. He founded confinis ag in 2005 and co-founded Medical Human Factors AG in 2016, a company specialized in evaluating the use-related safety, effectiveness and usability of medical products.

Regulatory Affairs Manager / Product Manager, DQS Medizinprodukte GmbH

Szymon Kurdyn

Szymon Kurdyn is the appointed Head of Notified Body NB 0297 (EU MDR 2017/745, MDD 93/42/EEC) with focus on non-active medical devices. he acted as certification scheme owner of ISO 13485 under CMDCAS and MDSAP, and well-experienced in managing relationships with various health authorities.He‘s a fully qualified as a body lead auditor for ISO 13485, MDSAP, MDD (MDD 93/42/EEC) and MDR (Regulation (EU) 2017/745) and routinely conducts such audits.