MCRA is pleased to announce its role in aiding CamDiab’s artificial pancreas software, CamAPS FX, in achieving U.S. Food and Drug Administration (FDA) clearance. CamDiab retained MCRA’s team of Digital Health and Quality Assurance experts to assist with the FDA submission process for the CamAPS FX app. 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. 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. Read the full press release here: https://lnkd.in/e4asCu5P #MCRA #pressrelease #predeterminedchangecontrolplan #PCCP #FDA #FDAsubmission #FDAguidance #FDAapproval #digitalhealth #SaMD #medtech #medicaldevice #medtechinnovation
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Chief Executive Officer at USA and International Research Inc.
1wCongratulations on this significant achievement! MCRA's expertise in navigating FDA clearance for CamAPS FX is commendable.