FDA Medical Device Tools Pilot Program

FDA initiated this pilot program as a way to quality fools for use by device manufacturers in their develpment processes. Qualification means that the FDA has evaluated the tool and concurs with available supporting evidence that the tool produces scientifically-plausible measurements and works as intended within the specified context of use. It focuses on cliinical outcome, biomarker, and non-clinical assessment models. FDA’s webpage on this pilot program is at the link provided. Since FDA will keep proprietary information confidential this approach may be attractive to tools vendors that want an FDA qualification statement but want to protect their proprietary information and not provide it to device manufacturers.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.