2016 EU Medical Device 5th Annual Roadshow

BSI is proud to host our fifth annual Medical Device Roadshow for the medical device manufacturer regulatory affairs, quality assurance and related consulting community. Our unique full-day Medical Device Roadshow event is the only annual education event exclusively focused on addressing European medical device regulatory and quality assurance landscape, and sharing current experience, best practice and latest expectations from the perspective of the leading provider of CE Marking, ISO 13485 and MDSAP certification relating to medical devices manufacturers in North America. 

Breaking News: On May 25th the European Council announced significant progress with the future EU Medical Device and In Vitro Diagnostic Regulations:  http://go.pardot.com/e/73472/es-2016-05-25-medical-devices-/571343i/178336298

BSI will review the EU regulations and provide expert practical implementation information at the Roadshow.

We invite you to join our panel of experts and networking with colleagues from the medical device RA/QA community to discuss critical updates and receive valuable insights from the leading medical device Notified Body, ISO 13485 registrar and worlds first national standards body.

Please join us in the city nearest you. REGISTER HERE

Early registration is suggested as 2016 is expected to be a high demand year with the changes to the EU regulations expected.

Preliminary Agenda of Topics*

  • Update on ISO 13485:2016 and possible next revision of ISO 14971
  • Unique Device Identification (UDI) expectations
  • EU Medical Device Regulation (MDR) Update (with practical implementation guidance)
  • Changing Clinical Requirements under the MDR and new MEDDEV
  • Designing Compliant/Risk Appropriate Post Market Surveillance (and Post Market Clinical Followup)
  • IMDRF Updates – Experience with MDSAP and RPS
  • IVD Breakout Session**
    • IVD Update – Including IVDR Top 10 Interesting Points
    • Performance Evaluation

*BSI reserves the right to vary the agenda to reflect the most appropriate and topical subjects at the time of the Roadshow
**Not available at the Minneapolis location