Designing medical devices for such varied use cases requires more than just technical proficiency. It calls for strategic ...

FDA Device Classification (Class I-III) based on the level of control necessary to ensure safety of the device. The FDA-required regulatory controls increase with increased class number.

New Delhi, The India-UK trade pact has incorporated a mutual recognition agreement framework to facilitate smoother entry of medical devices certified by domestic regulatory agencies into the British ...

India-UK trade deal eases market access for Indian medical devices in the UK. Zero tariffs and mutual recognition agreements ...

Different guidelines represent acceptable regulatory practices for all medical items. There are four risk classification levels of the medical devices (class I-IV, based on the risk level).

A clear intellectual property and product risk evaluation strategy helps device companies with investments and M&A.

State licensing for prescription medical device manufacturers and distributors is a complex and evolving landscape. While FDA oversees federal regulations, individual states impose their own ...

DUBLIN--(BUSINESS WIRE)--The "Contract Regulatory Affairs Management Market for Medical Devices, 2019-2030" report has been added to ResearchAndMarkets.com's offering.Contract Regulatory Affairs ...

That's in part because of a regulatory review process known as 510 (k) for a section of the FDA law covering medical devices. Manufacturers typically show their product has "substantial ...

DUBLIN--(BUSINESS WIRE)--The "European Handbook of Medical Devices Regulatory Affairs 2019" directory has been added to ResearchAndMarkets.com's offering. As medical device quality assurance and ...

If the device has been approved by the regulatory authority in the U.S., the U.K., Australia, Canada, or Japan, the device has been marketed in that country for at least 2 years, ...