10 THINGS YOU MUST KNOW ABOUT UPDATING YOUR TECHNICAL FILES TO COMPLY WITH EU MDR

The new EU MDR will affect all medical device manufacturers doing business in the EU.

The new regulation will bring significant changes with some of the largest coming from what is expected from your technical documentation.

How much remediation will be needed? What steps should you be taking now? What are the new expectations?

In this free 60 minute webinar presented by Sameer Jaiswal, a PRP Consultant & EU MDR SME, you will learn exactly what you need to do with your technical files to comply with the new EU MDR.

SPECIFICALLY This Webinar will Cover:

• The most important things you must know regarding your technical file to comply with EU MDR

• Why your technical file must truly be a living document 

• The new standard for proving equivalence

• Why you’ll now need to include more detailed QMS requirements

• How risk management is expected to be integrated

• And much more

Who should attend?

• Medical Device Industry Executives

• Regulatory Affairs Professionals and Management

• Quality Professionals and Management

• Clinical Affairs Professionals and Management 

• R&D Engineers and Management

About the Presenter:

Sameer Jaiswal is a PRP Consultant - EU MDR Subject Matter Expert. He has over two decades of experience working in the global medical device industry with companies such as Abbott Laboratories, Boston Scientific and Fujifilm Medical Systems. During his career, Sameer has been responsible for the clearance of numerous class II and class III devices in over 70 countries including major markets such as the US, EU, China and India. Currently, Sameer is consulting with a number of medical device companies seeking to comply with the demands of EU MDR.