In the EU, the AI Act has been approved, carrying significant implications for medical device, technology, and pharmaceutical firms. In the US, ...
When conducting a clinical investigation, meeting regulatory requirements is predicated on factors such as the quality of ...
MDR Certification Strengthens Resyca’s Leadership in Soft Mist Drug-Device Combination Products ENSCHEDE, NL / ACCESS ...
This rising trend mirrors the evolution of the pharmaceutical industry in terms of investment and utilisation of novel ...
Health Canada published a regulatory proposal in the Canada Gazette, Part I, Volume 158, Number 52, introducing amendments ...
The Food and Drug Administration (FDA) is spearheading efforts to boost the local manufacturing industry by creating ...
The new director of the FDA’s device center contrasted a ... Union now has access to “vital information about medical device ...
The U.S. Food and Drug Administration announced Wednesday it has revoked authorization for color additive Red No. 3 from food, beverages, and drugs. Health concerns over dye have existed since it was ...
The FDA is elevating a recall from Philips related ... we proactively identified a software configuration issue and reported a medical device correction, offering clinicians the possibility ...