510(k) consulting for respiratory medical device
Alacrita’s 510(k) regulatory affairs consultant worked with our UK medical device client to secure 510(k) clearance to for a non-contact respiratory measurement device. She provided strategic regulatory guidance and detailed technical input to develop an robust regulatory submission. We worked closely with the client’s in-house technical and regulatory team, providing expert counsel on the level of detail that FDA expected to see. We accompanied the company at FDA meetings, and helped the company respond to questions from the agency. Alacrita also supplemented the project team with expert medical device statistics and software specialists to develop the submission. Our client was granted 510(k) marketing clearance in March 2016.