The BSI’s UK & Ireland Medical Devices Regulatory Seminars in November are for all medical device manufacturers, regulatory affairs and quality assurance staff.
The full-day seminars are focussed on the European medical device regulatory and quality assurance landscape, sharing current experience, best practice and the latest expectations from the perspective of the Notified Body for CE Marking, ISO 13485 and MDSAP certification.
The seminars will also provide an opportunity to meet with a panel of experts and network with colleagues from the medical device regulatory affairs/quality assurance community to discuss critical updates and receive valuable insights.
Key topics will include:
- Major challenges facing manufacturers under the new MDR and IVDR
- Medical Devices Regulation (MDR) clinical requirements
- In Vitro Diagnostics Regulation (IVDR) update
- ISO 13485:2016 update
- MDSAP update
- Sterilisation and microbiology – pitfalls to avoid
- PPE regulation update
Registration costs £175 plus VAT, and attendees can choose from the following dates/locations:
Click here to register to attend.