Submitting 510(k) applications

Challenge

A medical device client needed help securing 510(k) clearance for a non-contact respiratory measurement device.

Solution

Our 510(k) regulatory affairs consultant provided strategic regulatory guidance and detailed technical input to develop a robust regulatory submission.

Working closely with our client’s in-house technical and regulatory team, we provided expert advice, with the level of detail that the FDA expects. We further developed the submission with expert medical device statistics and with help from software specialists. We accompanied our client to FDA meetings and helped them respond to questions.

Our client was granted 510(k) marketing clearance in March 2016.

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