Medical Device File

No matter where you are in the process of developing your medical device we can help generate your documentation to align with ISO 13485:2016.

Documentation can include the following:

• Device Description & Specification: Unique Device Identification (UDI-DI), intended use/purpose, intended user, principles of operation, and specifications.
• Design and Manufacturing Information: Technical drawings, Bill of Materials (BOM), material specifications, manufacturing processes, and supplier quality agreements.
• Risk Management File: Risk management plan, hazard identification, risk evaluation, control measures, and risk-benefit analysis.
• Verification and Validation Data: Reports for software, sterilization, packaging, and clinical evaluation (clinical evidence).
• Labeling and Instructions for Use (IFU): Product labels, packaging, and user manuals in required languages.
• Traceability and Compliance: Declaration of Conformity (DoC), evidence of conformity with General Safety and Performance Requirements (GSPR), and compliance standards.
• Post-Market Surveillance (PMS): PMS plan and reports, including Post-Market Clinical Follow-up (PMCF).