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:

  1. Device Classification.
  2. Identification of applicable standards.
  3. Risk management report and gap analysis.
  4. Clinical evidence report and gap analysis.
  5. Safety and biocompatibility.
  6. Guidance on suppliers/subcontractors agreements.
  7. Templates and checklists.
  8. Labeling & Packaging.

For further information about Technical Files, click here: Technical File Compliance.

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