SOP QualityAssurance


If your company receives FDA 483 observations for any of these procedures, Medical Device SOP Advisors will rewrite the SOP to satisfy the FDA observation and bring the SOP into compliance, at no charge. Of course, we are not responsible for your SOP customization, for the failure of your personnel to follow the SOP, or if your personnel are conducting activities that fall outside the written SOP. 


Click on "SOP's Available" to see descriptions of the SOP's available for sale



Similar to the return policies on software and other digital media of most retailers, we do not accept returns or offer refunds for our SOP products.

By accessing our website and/ or purchasing the medical device SOP Products you agree to hold us harmless from and against any and all claims, actions, and damages (including attorneys' fees) resulting from your use of our medical device SOP Products or the content of our website. If any legal actions are commenced as a consequence of your alteration or customization of our Product, you agree to idemnify Medical Device SOP Advisors for any attorney's fees expended by Medical Device SOP Advisors in connection with defense of same..

The medical device SOP Products are designed to be used for Quality Manuals as well as other guides and information. You are responsible for changes and customization and any information entered into a medical device SOP  that may subsequently be audited for compliance to regulations.