Quality Management Review For Compliance And Improvement

By Sarah Beale

The ultimate responsibility in a business lies at the top. In the regulatory world, this includes ensuring the quality system of a medical device company is effective. The specifics of how and how often the review should be conducted are a bit hard to pin down, but that’s by design. 21 CFR Part 820 has general guidelines, but leaves much of the “how to” up to individual companies.

Doing the bare minimum can certainly let companies pass an inspection, but quality management review can offer so much more than that. Like most regulations involving quality, 21 CFR Part 820.20 can be an item on a checklist or a valuable quality improvement tool.

Companies have some wiggle room when it comes to how they perform quality management review, but the FDA wants to see evidence of those reviews. Read more about quality management review regulations, a typical quality management review and how to ensure the reviews happen on schedule and per procedures.