Every company need to fully audit their entire QMS on a regular basis. The regularity can be defined by each company in their Quality procedures. It's best practice to have an audit annually. 

For small companies, it can be every 2 years. Typically audits are done on portions of the QMS at a time, so they get scheduled quarterly and have to cover the whole QMS every 1 or 2 years.

At the time of submission to the FDA and Notified body, an audit can be conducted on pre-submission activities. One quarter after commercialization, the post-market business processes should be audited.

Some states in United States require medical device companies to register their product 90 days before commercialization. Once the product is registered, the state can also audit the company. Generally an audit by the state occurs sooner than an audit from the FDA. 

If you have any questions, you can reach us through the in-app chat or email us at support@enzyme.com. 

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