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 ...

Arena International's Outsourcing in Clinical Trials: Medical Devices includes a session from a regulatory expert on how companies can align their research between regions.

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.

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 ...

The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices. Officials say the mov ...

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 ...

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 ...

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 ...

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

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" ...

South Korea’s medical device market is rapidly expanding, driven by technological innovations and increasing healthcare demands. As the market grows, understanding Korean medical device regulations is ...

The Asian economy has experienced tremendous gross domestic product (GDP) growth over the past decade and is expected to continue at a healthy pace for the next several years. The medical device ...