In May, the EU Medical Device Regulation (EU MDR) came into effect. What does this mean for medical device manufacturers marketing products to the European Union? And how will this regulation impact future medical device facility inspections?

For possible answers to these and other questions, download a recording of the Oct. 28 Redica Systems virtual panel discussion, “Changing Medical Device Regulations,” at 10 a.m. U.S. EST and 4 p.m. Central European Summer Time.

Two industry experts answered questions submitted during registration on the EU MDR and other medical device regulations.

Who Will Benefit

This virtual panel will be of interest to quality and compliance teams at medical device manufacturers that market products within the European Union.

About the Experts

Mark Agostino

Mark Agostino is a GMP Medical Device Expert at Redica Systems. He is also Managing Director of QARA Biomed. His areas of expertise include quality assurance and regulatory affairs for medical devices and combination products.

Alison Sathe

Alison Sathe founded Regulatory Mark and ClearMark to provide best-in-class regulatory and quality consulting and electronic quality management systems solutions for medical devices to her domestic and international partners.

Jerry Chapman

Redica Systems Senior GMP Quality Expert Jerry Chapman moderated the panel.

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