Learning Marketplace

2018 EU Medical Device Roadshow

Join BSI experts at our full-day EU Medical Device Roadshow where you can learn about some of the most significant changes to the European Regulatory and Compliance Expectations for CE marking. Enabling you to prepare for future requirements effectively.

Are you prepared for the significant changes to European regulations in order to maintain your CE marking?

BSI is proud to host our seventh annual EU Medical Device Spring 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 North American event exclusively focused on addressing European medical device regulatory and quality assurance requirements. BSI will be sharing our current experiences, best practice and expectations from the perspective of the leading global medical device Notified Body, ISO 13485 registrar and world’s first national standards body.

We invite you to join our international panel of experts to discuss critical topics and receive valuable insights around the significant changes we are all facing in 2018 and beyond.

Please join us in the city nearest you. 

Agenda

8:30am Welcome and Introductions
9:00am Here's what you can't do implementing the MDR
10:00am Coffee Break
10:15am A holistic approach to Clinical Requirements
11:00am Labeling and UDI
11:30am Certificates
12:00pm Lunch
1:00pm MDR FAQ
1:30pm Best practices for Technical Documentation
2:15pm MDSAP
2:45pm Coffee Break
3:00pm ISO 14971
3:30pm QMS Aspects of the MDR