Bradley Merrill Thompson, partner at Epstein, Becker & Green, discusses the Office of Combination Products and its development over the past decade, as well as the challenges it faces in the area of policy making, at MedTech Intelligence’s 2015 Combination Products Conference in Washington, DC.
After viewing the video, learn more about his thoughts on the alignment between OCP and CDRH, CDER, and CBER as well as the role of human factors in combination products.
The purpose of the Best Practices in Supply Chain Resiliency and Quality Working Group is to improve medical device quality and supply chain resiliency by expanding MedAccred adoption through the tiers in the supply chain, identifying best practices to supplement…
Jordi labs and its team of Ph.D. analytical chemists developed a proprietary, multi-detector approach to ensure that all extractables are accurately characterized to comply with global materials testing regulatory requirements.
Previous EU regulatory acts did not cover products without an intended medical purpose—typically devices with aesthetic indications. This now changes with Annex XVI of the EU Medical Device Regulation (MDR). Notified Bodies can assess these products for their conformity with…
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