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 ...

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).

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 ...

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 ...

The Global Handbook of Medical Devices Regulatory Affairs 2025 provides comprehensive, country-by-country insights into medical device regulations worldwide. Covering 70+ countries, it includes ...

DUBLIN, Jan. 3, 2020 /PRNewswire/ -- The "Contract Regulatory Affairs Management Market for Medical Devices, 2019-2030" report has been added to ResearchAndMarkets.com's offering.

According to the International Medical Device Regulators Forum (IMDRF), Software as a Medical Device is software intended to be used for one or more medical purposes, and is not part of a physical ...

Dublin, March 18, 2025 (GLOBE NEWSWIRE) -- The "Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course" has been added to ResearchAndMarkets.com's offering ...

The FDA has finalized its regulatory rule that aims to bring laboratory-developed tests more in-line with how the agency oversees other diagnostics. At its heart, the 528-page final rule (PDF ...

Per a report by MordorIntelligence, the global COPD devices market is anticipated to see a CAGR of 5.2% from 2020 to 2025. The encouraging projection has been largely backed by the steady rise in ...

Dublin, June 30, 2025 (GLOBE NEWSWIRE) -- The "Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course" training has been added to ResearchAndMarkets.com's ...