What are your primary concerns about the EU Medical Device Regulation (EU MDR)? Are there specific challenges your company is facing with understanding the requirements of the regulation?

On Thursday, Oct. 28, two leading industry experts offered their insights into the EU MDR and other medical device regulations for a virtual panel discussion, “Changing Medical Device Regulations.” The two-person panel consisted of Redica Systems GMP Medical Device Expert Mark Agostino and Regulatory Mark Founder Alison Sathe.

Redica Systems Senior GMP Quality Expert moderated the panel.

Who are the Experts?

  • Mark Agostino is the latest addition to our Industry Experts and has experience with quality assurance and regulatory affairs for medical devices and combination products.
  • Alison Sathe consults on electronic quality management systems solutions for medical devices with both domestic and international partners. In June, she was one of the presenters for the Redica Systems webinar, Human Factors | Compliance and Applications.

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