On February 2, 2024, the US Food and Drug Administration (FDA) published a much-awaited final rule: the Quality Management System Regulation (QMSR). 1 By issuing this rule, FDA amended the medical ...

Medical device labeling is considered as important as classifying a product or creating an insulation diagram. In IEC 60601-1, labeling is deemed "a critical component of a medical device." 1 The ...

Pat Shrader, Medtronic’s vice president for global regulatory affairs, testified (PDF) at a House subcommittee hearing this week, urging Congress to “improve” the inspection of medical device ...

In this month’s post, in the medical device realm I explore what kinds of inspection citations most often precede a warning letter. In this exercise, I do not try to prove causation. I am simply ...

When was your last FDA inspection? You may believe that the likelihood of an FDA inspection happening to your company is low. However, medical device companies registered with FDA with class II and ...

Regulatory oversight has instead been exercised by the NAFDAC pursuant to its general mandate under the NAFDAC Act (Cap N1, ...

The ‍ ‌‍ ‍‌ ‍ ‌‍ ‍‌ medical technology sector has been a leader in innovation for a long time, and now the regulations are changing accordingly. As a result of digital transformation and worldwide ...

Just 27% of 230 medical device makers surveyed expect to be in full compliance with the European Union’s Medical Device Regulation (MDR), which goes into effect in May next year, a study has found.

City, India, December 23, 2024: In a significant step toward ensuring global quality standards, Indian pharmaceutical, nutraceutical, and medical device manufacturers are enhancing their Good ...