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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 ...
JD Supra1d
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, ...
Business Wire3d
Pharmaceutical Regulatory Affairs Market Trends Analysis Report 2025-2030: Demand for Faster Approval for Breakthrough Drugs and Devices, Growth in Personalized Medicine ...
For instance, in October 2022, Freyr partnered with an orthopedic implant manufacturing company in Korea, and as per the agreement, provided it with regulatory device registration and legal ...
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 ...
JD Supra10d
New Regulatory Amendments Under the Food and Drugs Act: Addressing Drug and Medical Device Shortages in Canada
Health Canada published a regulatory proposal in the Canada Gazette, Part I, Volume 158, Number 52, introducing amendments ...