CONSULTANCY /
Technical Documentation
Comprehensive technical documentation is fundamental for placing a medical device on the market. This includes detailed information on design, manufacturing processes, risk management, clinical evaluation, and post-market surveillance. Well-structured documentation that aligns with legal requirements in the territory will proceed through review and get devices to market more quickly. Whether you’re preparing for certification or updating existing files, we can help you compile, review, and maintain compliant technical documentation.
Compilation & Review
- Assistance in creating technical files for regulatory approval.
- Review and gap analysis of existing documentation.
- Ensuring alignment with MDR/IVDR and other applicable regulations.
Regulatory Submission Support
- Preparation of technical documentation for Regulatory and Notified Bodies and Competent Authorities.
- Guidance on Clinical Evaluation Reports (CERs) and risk management files.
- Support with Post-Market Surveillance documentation.
Ongoing Documentation Maintenance
- Keeping documentation up to date with regulatory changes.
- Assistance in implementing changes from post-market data and corrective actions.
- Long-term support to ensure compliance throughout the product’s lifetime.