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

Hohenstein Medical said the Good Laboratory Practice certification expands its ability to support regulatory needs of device manufacturers.

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

The Nigerian Midstream and Downstream Petroleum Regulatory Authority (NMDPRA) has recommended stricter measures for fuel ...

The regulatory pathway would allow companies to undergo a two-stage process by which devices are approved once as each of its components and once as a holistic review of the devices.

[7] Gail A. Van Norman, Drugs, devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices, 1 JACC: Basic to Translational Science 277, 277, 283 (2016).

Contract Regulatory Affairs Management Market for Medical Devices, 2019-2030 - ResearchAndMarkets.com January 03, 2020 10:29 AM Eastern Standard Time ...

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 ...

In this hoganlovells.com Q&A, Hogan Lovells counsel Fabien Roy addresses EU regulations that apply to medical devices that are produced using 3-D printing technologies. In 2015, the UK ...

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, and the data of ...