The client is a top distributor of medical devices in Saudi Arabia was looking for assistance in closing their external audit findings (8 audit findings). The client did not have any internal QMS and there was no dedicated QA resource /team. This proved to be a big challenge for the Freyr team. With tight authority deadlines, Freyr completed the final response document and ensured the submission of response document along with relevant artefacts within 4 days.

Read through the case to know how Freyr addressed all the challenges and explained the client the importance of risk-benefit analysis.