Challenge: Eximis Surgical sought assistance in taking their startup from the early stages as an R&D company to implementing an ISO 13485 compliant QMS.
Solution: QA Consulting, Inc. developed standard operating procedures (SOPs), wrote and executed software validation protocols, and provided flexible document control support.
Outcome: QA Consulting provided an FDA/ISO compliant QMS and the structure our R&D team needed to create design history files (DHF) for submission to regulatory bodies.
Why QA Consulting? The QA Consulting team is a one-stop-shop that offered all the expertise we needed to meet our business objectives.
“What I appreciated is the breadth of services that QA Consulting Inc. provided, including expertise with Grand Avenue Software. They offered quick and efficient QMS SOPs, and were pleasant to work with.” ﹣Diane Keyser, Director of Quality Assurance, Eximis Surgical
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