“Through a combination of expertise, experience, and excellent customer service, USDM provided the tools we needed to submit for our 510(k) and receive clearance ahead of our schedule.”
-Adam Rosenzweig, General Manager, ARC-One
- USDM worked with the quality assurance (QA) and regulatory affairs (RA) managers, and the
- USDM reviewed more than 100 supporting documents for the submission, then drafted the body of the 510(k)
- FDA clearance was received weeks ahead of customer’s deadline
ARC-One Solutions, LLC was created in April 2020 through a partnership between two of the largest blood centers in the country, the American Red Cross and OneBlood. ARC-One Solutions has the privilege and responsibility to assist these organizations in fulfilling over 50% of the nation’s blood supply needs. Once implemented, their software will process approximately 10 million products across 56 states and territories.