Medical device startups have a pile of things to address yet often don’t have the pile of money to take care of everything that is needed. Because of this, a medical device quality system often gets ...

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 ...

FDA has published and makes available ALL regulations required for medical device companies. Look them up by searching 21 CFR part 820. And for outside U.S., you can easily obtain ISO 13485 for a ...

In February 2026, the medical device industry will be faced with new regulatory challenges that could shake up operations. The good news? Companies that are already in compliance with existing FDA ...

On February 22, 2022, the Food and Drug Administration (FDA) proposed a long-awaited rule to amend its Quality System Regulation (QSR), which is codified at 21 CFR Part 820 and sets forth current good ...

Dublin, Sept. 22, 2025 (GLOBE NEWSWIRE) -- The "US FDA Medical Device Quality System (QSR) Compliance: Design Controls, Verification & Validation (Oct 27th - Oct 28th, 2025)" training has been added ...

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 ...

Dublin, Sept. 23, 2025 (GLOBE NEWSWIRE) -- The "Bottlenecks to Flow: Optimizing Design Controls and Validation in Medical Device QMS (Oct 23rd - Oct 24th, 2025)" training has been added to ...

Rigorous Audits Confirm that Echo Meets the International Organization for Standardization's Requirements for the ISO 9001:2015, ISO 13485:2016, and ISO 14001:2015 Standards CHICAGO, June 22, 2020 ...

RA'ANANA, Israel, July 24, 2023 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the "Company" or "Inspira Technologies"), a company aiming to revolutionize acute ...

The Health Sector Coordinating Council’s Cybersecurity Working Group today released a best practices guide for health care organizations and medical device manufacturers that includes an updated ...