Opinion: Medical device companies can create a competitive advantage by leveraging data to strengthen compliance programs and by ensuring effective oversight of quality and regulatory reporting ...

On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule 1 amending the device good manufacturing practice (GMP) requirements of the Quality System Regulation (QSR) 2 ...

After a long wait, the U.S. Food and Drug Administration (FDA) recently published a Final Rule to harmonize the Quality System Regulation (QSR) codified at 21 C.F.R. Part 820 with the internationally ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

Legacy medical devices face growing scrutiny as regulators push for stronger cybersecurity, transparency and risk management.

But as these products proliferate, manufacturers face a new set of questions. How do expectations around comfort, usability, ...

Modern conveyance systems help medtech manufacturers achieve flexibility, compliance, and integration in smart factories.

WESTBROOK, ME—Systems integrator Lanco has been awarded a contract to design and build an automated, pallet-based test system for high-volume production of a medical device.

Penta Nanotechnology (Suzhou) Co., Ltd. has officially announced its attainment of the ISO 13485 certification, marking a significant milestone as a premier Certified Parylene Coating Equipment ...