Gap Analysis & Technical File Reviews
iCertifi offers detailed TR Reviews & Gap Analysis of devices, systems or product families
- Confirm the Technical Construction File has all the required documents
- Review and validate all regulatory & device documents
- Assessment/Confirmation if appropriate Test Standards & Directives were applied
- Confirmation that correct Family Designation justification are valid
- DoC generation service
- Findings Reports with items to be mitigated called out
- Testing coordination and scheduling services for test the mitigated items
- Preparation of the technical dossier and approval forms
- Application package submission to Authorities
- International standards identification