Technical File Services
Obelis Technical File services include the review and gap analysis of an existing Technical File, as well as the creation of a complete and compliant Technical File.
Our Technical File Review/Creation services include, but are not limited to, the following:
- Device Classification.
- Identification of applicable standards.
- Risk management report and gap analysis.
- Clinical evidence report and gap analysis.
- Safety and biocompatibility.
- Guidance on suppliers/subcontractors agreements.
- Templates and checklists.
- Labeling & Packaging.
For further information about Technical Files, click here: Technical File Compliance.