Our Experienece
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Summary of Technical Documentation (STED) per IVD
- Many Documents to be used in STED are as per IVDD not IVDR
- Basic UDI-DI details were not available
- For some products previous and/or similar generation of device details are tough to provide
- IVDR STED
- IVDR Appendix 4.1- GSPR( General Safety and Performance requirement)
- Technical File Tracker
- Technical File Status Tracker
- PMS Plan, PSUR, PMSR
- Ovid MEDLINE®
- PubMed
- Scopus
- Google Scholar
Case Studies
We have provided a few projects which we have executd for our customers. Please reach out to us for more details