We provide end-to-end solution to achieve CE Certification and other FDA approvals.
Incase you are in a plan to transit from MDD to EU MDR or IVDD to IVDR, Please reach us to discuss:
1. Complete transition strategy from MDD to MDR or IVDD to IVDR
2. We offer complete package solutions to start-ups, AI Based companies, SaMD and small organizations setting up QMS.
3. We can develop Medical Device Technical File, Clinical Evaluation Plan and Report, Literature Search, Risk File, Usuability Engineering, General Safety Performance, Post Market Surveillance, IFUs, Product Label verification and Biological Evaluation.