IVDR Compliance & Implications for IVDD Self-Tests

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Archived Webinar

IVDR Compliance & Implications for IVDD Self-Tests

Erik Vollebregt, Partner
Axon Lawyers

Recorded on October 8, 2020

Overview of changes & IVDR timelines
Conformity assessment & classification
General Safety and Performance Requirements
Emphasis on compliant labeling & IFU
Clarifying clinical & post-market requirements

Download Here

PRICING
This webinar is available for download for $249.

TARGETED AUDIENCES
Clinical
Regulatory

INDUSTRIES REPRESENTED
Diagnostics

Presenter:

Erik Vollebregt, Partner
Axon Lawyers

Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities and M&A. He actively contributes to law and policy development at national and EU levels via membership of specialized committees at branch associations.

Erik also works as arbitrator in medical devices related disputes and is regularly retained as expert witness in foreign litigation. He is author of the acclaimed Medicaldeviceslegal.com blog on EU medical devices regulation.

For More Information, Contact:

Brooke Akins
Division Director, Life Science Programs
+1 (312) 224-1693
bakins@q1productions.com

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