Remove 2028 Remove Medical Device Industry Remove Regulatory Compliance
article thumbnail

A Step-by-step guide to Medical Device Quality System Management

Dot Compliance

Millions of dollars are lost by manufacturers every year due to regulatory non-compliance issues and related lawsuits. We continuously hear of infractions and warnings issued to companies for lack of regulatory compliance. The FDA 21 CFR Part 820 is the mandatory standard for medical devices distributed in the US.

FDA 52