BSI to hold medical device regulatory seminars next month

The full-day seminars are focused on the European medical device regulatory and quality assurance landscape, sharing present 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 make available an opportunity to meet with a panel of specialists 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 needs
  • In Vitro Diagnostics Regulation (IVDR) update
  • ISO 13485:2016 update
  • MDSAP update
  • Sterilization and microbiology – pitfalls to avoid
  • PPE regulation update