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 |