FDA Changes Policy to Inspect Audit Reports. On January 31, 2024, the FDA published a final rule called the Quality […]

FDA amends cGMP requirements in QSR (21 CFR Part 820) Quality Management Systems Rule (QMSR) Final Rule, published by the

Compliance with JIS T 62366-1:2022 By March 31, 2024, medical device companies shall comply with the basic requirements for medical

Readers may be familiar with an anecdote called the boiled frog phenomenon.If a frog is thrown into boiling water, it

If you work for a pharmaceutical or medical device company, the first thing you learn is how to correct raw

What is state of the art? “state of the art” means “of the latest technology, most advanced”. ISO 14971:2019 “Medical

Why does FDA require DHF creation Regarding DHF, last month also explained, but I would like to address it again

Cyber Security Handbook and IEC 81001-5-1 There are two regulatory requirements for cybersecurity response in Japan.The “Guide to Implementing Cybersecurity

What is Process Validation In medical device manufacturing, many inspections are nondestructive. Therefore, inspection of all products is possible. In

History of FDA Medical Device Regulation On July 21, 1978, FDA issued a final rule in the Federal Register (43