Innovators wanting to market their products must first review the existing HA regulatory framework for medical devices to determine the correct pathway. The first step is to assess whether or not ...

Another critical issue is the regulatory pathway for medical devices in the United States, particularly the 510(k) pathway, which allows new devices to be authorized based on their similarity to ...

The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional ...

Medical device consulting in the constantly changing landscape of the 510(k) review and clearance process has always been exciting.

The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...

The 2024 study, of 202 regulatory professionals at Class 2 and 3 medical device companies in the EU (Germany) and North America (the US), started by reviewing medical device suppliers ...

This concentration (and certificate when approved) is designed for professionals working in the industry who want to enhance their knowledge of the legal, regulatory and ethical frameworks surrounding ...

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

Centres of Excellence for Regulatory Science and Innovation (CERSIs) to help drive advancements in healthcare.Pioneering use of artificial intelligence (AI) could cut the time it takes to bring ...

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 ...