A UK-based healthcare organization approached Freyr for end-to-end Regulatory support for their legacy devices and combination products’ EU MDR transition. The transition was to be implemented in a tri-phasic approach and required to meet varied Regulatory requirements, as the devices were of different risk categories. In addition to the inconsistencies in the legacy device documents, the major challenges were to update, review and perform gap analysis for all the device technical files.
Read through the case study to know how Freyr provided timely and compliant end-to-end Regulatory support, to navigate the EU MDR transition with ease. Download.