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.

The clock is ticking for medical device and pharmaceutical companies to fulfill their obligations under the Physician ...

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

“The new Post-Market surveillance regulations will provide us with more safety information on medical devices in use in GB, ...

In the United States, the biomedical industry encounters numerous regulatory challenges in conducting nonclinical and ...

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

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.