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.

Upcoming Training

Agile Methods for Medical Device and Health IT Software

One day course that expands on the software risk management topics covered in our IEC 62304 and other Emerging Standards for Medical Device and HealthIT Software course. Essentially the same topics are covered but in greater depth with more attention to hands-on analysis of examples.

Email training@softwarecpr.com for more info.

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