Client Need
CamDiab Ltd is a digital health and personalized medicine company focused on the design, development, and commercialization of its world leading, interoperable CamAPS FX closed loop app. CamDiab retained MCRA’s team of Digital Health and Quality Assurance experts to assist with the FDA submission process for the CamAPS FX app.
CamDiab successfully obtained FDA clearance for their CamAPS FX app with the support of MCRA.
MCRA Approach
Due to the nature of the software used, the MCRA team assembled a pre-determined change control plan (PCCP) to ensure the software could be updated easily, without the need for additional FDA submissions.
MCRA THERAPY: Digital Health
MCRA SERVICES: US Regulatory, Quality Assurance
Outcome
The pre-determined change control plan is an impressive achievement for MCRA and CamDiab, as it is a relatively new concept from the FDA with a high-level of expertise needed. In the end, CamDiab successfully obtained FDA clearance for the CamAPS FX app with the support of MCRA.
“CamDiab is grateful for the invaluable support provided by MCRA’s team in achieving FDA clearance for our innovative diabetes treatment app, CamAPS FX. The dedication and expertise of MCRA’s Digital Health and Quality Assurance teams were instrumental in our success, and we appreciate their tireless efforts in paving the way for this milestone.”
