Medical Device Regulation: From a product testing and certification perspective
Medical device manufacturers face new challenges when trying to access the European
market due to the recent publication of the new Medical Device Regulation (MDR). The MDR
will have a significant impact on clinical, pre-clinical and biocompatibility
performance as well as other technical requirements.
This webinar will introduce you to the changes and how they will impact your Electro-
Medical product research, design, development through to placing your product on the
European market. The new regulation will bring about significant changes for your
business and it's important to understand the implications early and start planning
your transition immediately.
About the Strategic Alliance of CSA Group and BSI:
The alliance between CSA Group as one of the world's leading medical device testing
and certification organizations and BSI, one of the leading Notified Bodies in Europe,
brings together an unrivalled mix of expertise, enabling you to create and bring your
medical devices to patients and healthcare professionals all over the world - FAST and
PREDICTABLY. We understand that speed and certainty about project deadlines is paramount
when accessing global markets. Therefore, our one-stop service guides electro-medical
device manufacturers through the key stages of market access:
- Product Testing according to IEC 60601
- CE-Marking incl. Technical File Review
- Quality Management System Assessment according to ISO 13485
Hans Gerd Evering is a BSI Certification Lead and Product Technical
Specialist, and works from both the company's Milton Keynes and Frankfurt offices.
In his role at BSI, Hans Gerd manages clients' certification as a Scheme Manager,
assesses their technical files as a Technical Specialist and audits their quality
management systems as an Auditor. Hans Gerd has experience as a Team Leader for other
Product Specialists, and continues to deliver BSI training courses.
Stefan Hofmann is in charge of CSA Group's medical team in
Frankfurt and responsible for the medical device business of CSA Group in Germany and
other parts of Europe. In addition, he is the main contact for local accreditations of
CSA Group' medical laboratory in Frankfurt (DAkkS/ZLG/IECEE/SCC/OSHA) and
represents the company in German Standard Committees in Germany (DKE). He is also an
IECEE Assessor (CB Scheme).