JD Supra8h
International AI Regulatory Contrast: Evolving frameworks in the EU, UK, and US
In the EU, the AI Act has been approved, carrying significant implications for medical device, technology, and pharmaceutical firms. In the US, ...
GlobalData on MSN1d
OCT Medical Devices 2025: biggest regulatory requirement issues ‘start at the site level’
When conducting a clinical investigation, meeting regulatory requirements is predicated on factors such as the quality of ...
interaksyon.philstar2d
‘Unauthorized’: FDA issues warning on 2 Rosmar Tan’s beauty soaps
The Food and Drug Administration (FDA) of the Philippines has warned the public against purchasing two beauty soaps by ...
Resyca Receives Medical Device Regulation Certificate From TÜV SÜD
MDR Certification Strengthens Resyca’s Leadership in Soft Mist Drug-Device Combination Products ENSCHEDE, NL / ACCESS ...
FierceBiotech15d
FDA elevates Philips cardiac telemetry recall over unflagged ECG alerts, following 2 deaths
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 ...
JD Supra17d
FDA’s evolving regulatory framework for AI use in drug & device clinical trials and research
FDA Medical Device Regulation Over the Use of AI in Clinical Trials As FDA noted in the JAMA article, artificial intelligence and machine learning (AI/ML) have many potential uses in clinical ...
China Internet Information Center27d
China deepens comprehensive reform to strengthen drug, medical device regulation
The guideline stipulates that by 2027, the legal and regulatory frameworks for drug and medical device supervision will be more enhanced, while the quality and efficiency of review and approval ...