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.
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
Medical Device Industry Executives
Regulatory Affairs Professionals and Management
Quality Professionals and Management
Clinical Affairs Professionals and Management
R&D Engineers and Management
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.
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Since 2012, Professional Resource Partners has been honored to serve as a trusted source of quality and regulatory compliance talent to the medical device and pharmaceutical industries. As a certified woman-owned business, PRP is proud to deliver exceptional professional integrity and a positive customer experience to each of the many clients it supports with its customized consultancy. It’s also the reason why, when PRP is involved, client expectations are not simply met, but they are consistently surpassed.