Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...
Opinion: The Food and Drug Administration's updated guidance on wellness devices will help ensure that products are appropriately positioned in the market—while staying away from unsupported, ...
FDA's new medical device quality management rules align U.S. standards with global requirements and give inspectors new ...
Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...
The FDA has announced that it will relax portions of its regulatory framework governing wearable health devices, a move the agency says is designed to encourage innovation and expand consumer access ...
Instead of making life easier for medical device companies, the FDA’s new wearables guidance makes the market more complex.
Facet Life Sciences, a regulatory affairs and product development strategy partner, is proud to announce the release of the second edition of FDA and Intellectual Property Strategies for Medical ...
The context-aware, multi-lingual AI agents act like a 24/7 digital FDA reviewer, helping MedTech companies improve ...
The main take-home message is that regulatory approval doesn't mean a device works. It means it's safe,” according to Katya ...
The designation supports priority engagement with the FDA as Portal Diabetes advances clinical trials and regulatory submissions.
Some results have been hidden because they may be inaccessible to you
Show inaccessible results