Fuzz testing for Medical devices & FDA | Paper

“Fuzz testing is state-of-the-art for testing robustness. Although you can write your own tests, you can never perform as many random and denial-of-service tests as you can with fuzzing. You must perform fuzz testing to prove to the FDA that your device is reliable and that the most common bugs are caught.”

Verena WieserMedical Device Consultant, Lorit Consultancy

When developing a new medical device and seeking market approval

If the company is not compliant with the requirements, it risks failing the submission for market approval and not getting clearance for the US market. Resubmission implies extra costs and can take months.

When already selling devices on the US market

Medical device manufacturers undergo regular audit checks. If an auditor notices a nonconformity with any of the requirements, the company needs to resolve the nonconformity within a certain timeframe. Download the white paper to learn more.

Fuzz testing in FDA’s requirements for medical device security

Inside you'll discover:

Inside, you'll discover:

Medical Devices Security: the role of fuzz testing

When to comply with the FDA’s security requirements