A UK-based client approached Freyr for assistance in establishing QMS compliance for their medical device software as per ISO 13485:2016 requirements. Additionally, the client needed Regulatory support for medical device technical file remediation, ad-hoc consulting support, and QA FTE support to the QMS project. However, the client was not familiar with ISO 13485 requirements, and it was challenging for Freyr to research and work on the Regulatory roadmap for client approval and prepare all the technical file documentation from 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.