This online certificate program at Purdue University focuses on regulatory affairs science for medical devices. It equips professionals with knowledge in regulatory processes, quality systems and ...

As the saying goes, time is money, and this statement could not be more true for the medical device industry. Each day that passes when a device is not approved for marketing is a day of revenue loss.

FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less regulatory oversight.

RALEIGH, N.C.--(BUSINESS WIRE)--Veranex, the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry, announced today that it has acquired an ...

State licensing for prescription medical device manufacturers and distributors is a complex and evolving landscape. While FDA oversees federal regulations, individual states impose their own licensing ...

All medical devices have risk. “You, as the manufacturer, are responsible for determining the risk of your medical device and if that risk is acceptable,” said Joseph Tartal, FDA deputy director in ...

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 Course" ...

As the biopharma space gets more competitive and the days of blockbuster drugs seem further in the rearview, biopharma companies are investing in digital to find new and innovative ways to ...

Singapore-based Andaman Medical has become the first regulatory affairs consultancy focused purely on medical devices and the ASEAN region to win ISO certification for medical devices. Andaman ...

Shortages of critical medical devices during the COVID-19 pandemic exposed vulnerabilities in device markets. From 2010 to 2019 there were approximately five shortages annually, but that number ...