Medical Device Market Access - Frequently Asked Questions
The requirements for medical device market access can be complicated. There are various Regulations, Directives and Standards that medical devices must comply with before they can be sold on the market, which vary from market to market. Further, a number of these documents have recently been revised, or are due to go through transition.
Quality and regulatory affairs teams must therefore ensure that they fully understand the intricacies of these requirements to ensure on-going compliance.
This webinar will provide answers to the most frequently asked questions during the market access and approval process of electro-medical devices. You will also get the chance to ask individual questions to our expert speakers.
Vishal Thakker is a Product Technical Specialist and Scheme Manager in the BSI Active Devices team. Vishal’s role includes managing the certification process for customers seeking European market access.
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).