Frequently Asked Questions
Are Class II and Class I devices exempt from QMS requirements?
No. It is important to note that Class II devices and most Class I devices are not exempt from QSR (GMP) requirements.
My company already has ISO 13485, is that sufficient?
The FDA does not recognize ISO 13485 as being in compliance with FDA QSR (21 CFR Part 820). However, if you already have ISO certification, we can assist you in integrating FDA quality system requirements into your existing QMS.
How long does it takes to implement FDA QSR - 21 CFR Part 820
The amount of time needed to comply with 21 CFR Part 820 can vary widely depending on how many facilities you have, the complexity of your manufacturing process, and whether there is someone in the company dedicated to quality management with the full support of management. Over the years our experience has shown that most medical device and IVD manufacturers are able to implement a QSR compliant QMS in three to seven months.
Where can I find a copy of the QSR?
We offer an interactive copy of 21 CFR Part 820 and other relevant FDA regulations here.