Medical Devices-EU MDR Compliance

In this webinar, you will gain understanding of what the EU MDR is and why it came into effect. In addition, you will learn the current transition times, the changes from the MDD, and the EUDAMED reporting requirements.

Outline:

• What is the EU MDR and why did it come into effect?
• What are the current transition times?
• What are the changes from the MDD?
• EUDAMED and reporting requirements
• Role overviews (Person Responsible for Regulatory Compliance, Authorized Representative, importers and distributors of medical devices).

Who should attend:

• Quality Assurance/Control
• Regulatory Affairs
• Personnel working on Technical File submissions
• Anyone interested in learning more about this topic

About the Presenter:

Jason Jegge, MWA Associate

Jason Jegge is a principal consultant with MWA Consulting. He has worked in the medical device industry for over 30 years within product, project and process development engineering spanning clinical, quality and regulatory management leadership positions. Product submission experience includes Class I, II, IIa, IIb and Class III, 510k, DeNovo, BLA, IND, NDA, PMA, implantable, diagnostic and disposable devices. Jason holds a Bachelor of Science degree in Mechanical Engineering (with a medical device emphasis).

About MWA:

Founded in 1985, MWA Consulting, Inc. provides exceptional compliance consulting expertise from development through commercialization for the pharmaceutical, biotechnology, cosmetics, dietary supplements and medical device industries. We are a trusted and reliable choice for your compliance consulting projects and audit needs.