Siemens’ Closed Loop Quality and Compliance for Medical Devices solution facilitates uninterrupted traceability of the compliance approach, ensuring preparedness for recalls and comprehensive control ...

When conducting a clinical investigation, meeting regulatory requirements is predicated on factors such as the quality of ...

DUBLIN--(BUSINESS WIRE)--The "The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training ...

MedTech Europe’s report reflects a lack of clarity over requirements, rising costs, and decreases in innovation activities.

Proper storage of medical products is critical due to their potential sensitivity to environmental conditions, such as ...

MDR Certification Strengthens Resyca’s Leadership in Soft Mist Drug-Device Combination Products ENSCHEDE, NL / ACCESS ...

IntroductionIn the rapidly evolving healthcare landscape, medical devices play a pivotal role in enhancing patient care and improving health outcomes. The road to getting these devices from concept to ...

In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued ...

In the EU, the AI Act has been approved, carrying significant implications for medical device, technology, and pharmaceutical firms. In the US, ...

Health Canada published a regulatory proposal in the Canada Gazette, Part I, Volume 158, Number 52, introducing amendments ...

This decision, revealed during a joint workshop with the Confederation of Indian industry on medical device regulation, underscores growing concerns about patient safety and compliance gaps.