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

Standalone Modules

Module 3 - EU Medical Device Regulations Part B

 

Content

Module 3 delves into the regulation of all life cycle phases from research and development to submission of a medical device with a focus on the European market. The module aims to provide participants with the skills and knowledge to identify and apply quality, safety, and effectiveness requirements of a medical device and to provide them with comprehensive knowledge on documentation requirements.

Start & Duration

Module 3 starts in January each year. 
The completion takes approximately 12 weeks.

Credits

6 ECTS

Fee

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

Reference

03.003

 

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.

Regulatory Affairs Manager Strategic & Digitized Data and Documenation at DePuy Synthes

Pamela Joller

Pamela Joller has more than 15 years of experience in regulated industries, where she began her career in the Regulatory Affairs department for DePuy Synthes, companies of Johnson & Johnson. Pamela leads and manages regulatory activities as a business/product owner in global strategic IT PLM solution implementations (focus on EU regulations) including systems such as Agile e6 (Oracle), SAP (ERP), MDS (Master Data) and Windchill. She has an Executive Master's degree in IT Management (2021) which includes Certificates of Advanced Studies (CAS) in IT Management, Applied Psychology, and Project Management.

Former Global Lead of Quality and Regulatory Functions at Pall Corporation

Heike Idink

Heike Idink has 30+ years of experience in regulated industries including 13 years with Pall Corporation, where she was the global lead of the Quality and Regulatory functions. She contributed to further improvement of a harmonized EU medical device legislation working for more than 15 years in various trade associations in Germany, Switzerland and at European level. She received a Diploma of Mineralogy from the RWTH Aachen University, Germany, a PhD of Natural Sciences from Penn State University, USA / RWTH Aachen University, Germany, and a Master of Business Law from FFHS, Switzerland.