A UK-based client approached Freyr for assistance in establishing the QMS compliance for their medical device software as per ISO 13485:2016 requirements. Additionally, the client needed the Regulatory support for medical device technical file remediation, ad-hoc consulting support, and QA FTE support for the QMS project. However, the client was not familiar with the ISO 13485 requirements, and it was challenging for Freyr to research and work on a Regulatory roadmap for client approval and prepare all the technical file documentation from the pre-existing QMS.
Amidst these challenges, how did Freyr provide end-to-end Regulatory support to the client for QMS implementation as per ISO 13485 requirements? What were the client benefits? Read through this proven case.
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