"Reverse" FDA Compliance

Publisher: apartis Information Management

Access this content

Your content has been opened.

Please verify you are a human before downloading this content.

"Reverse" FDA Compliance has been emailed to . Entered the wrong email?

Don't see the content in your inbox?
Make sure to check your spam and other messages folders.

Can't get to your email right now?

To complete your registration and access this content, enter the sign-in code sent to your email.

Please enter a valid verification code.

Code sent to:

Also, remember to check in your spam, promotions, and other folders.


Register to access this content


By accessing content on the Medical Device Directory you agree to our Terms of Service and Privacy Policy; and, you acknowledge that your information may be shared with the content publisher.

 "Reverse" FDA Compliance

Retroactive development of approval documents apartis produced the FDA-approval documentation in accordance with 510(k) and 21CFR, part 11 for medical equipment software that had been developed previously. We developed and executed missing software validation test cases and created a trace matrix and complete software design history file. This enabled the manufacturer to launch their hardware and software on the American market.