Learning Marketplace

2019 EU In Vitro Diagnostic Regulation Workshop

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The IVD industry is undergoing significant change. Join BSI experts at our In Vitro Diagnostic Regulation Workshop where you can learn about some of the most significant changes to the European Regulatory and Compliance Expectations for CE marking.

Correct IVDR Compliance = EU Market Access

BSI is proud to host our inaugural EU IVDR Workshop for the IVD manufacturer regulatory affairs, quality assurance and related consulting community.

Our unique EU IVDR Workshop event is exclusively focused on addressing the European IVDR. 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, MDSAP Auditing Organization and world’s first national standards body.

Topics and Schedule

8:30am – 8:45am Welcome and Intro
8:45am – 10:00am IVDR Overview, Classification, Grouping Devices
10:00am – 10:15am Coffee break
10:15am – 10:45am Interacting with the Notified Body
10:45am – 11:30am Technical Documentation Requirements
11:30am -12:00pm New Requirements for Performance Evaluation
12:00pm - 1:00pm Lunch
1:00pm – 2:00pm Post-launch Requirements
2:00pm - 2:15pm Coffee break
2:15pm – 3:15pm Workshop: Using the Remaining Transition Period Effectively
3:15pm - 3:30pm Some Common Pitfalls
3:30pm - 4:00pm Wrap up and Questions