Creating Technical file
Creating a comprehensive and compliant technical file is essential for bringing medical devices to market. Our consultancy specializes in developing detailed Technical Files that meet the stringent requirements of regulatory authorities such as the EU MDR, FDA and other regulations. We ensure your documentation is thorough, accurate, and fully compliant, facilitating a smooth approval process.
Our Technical File Creation Services Include:
- Documentation Compilation: We gather and compile all necessary documents, including design and manufacturing details, risk management files, clinical data, and post-market surveillance plans. Our team ensures every aspect of your medical device is meticulously documented.
- Regulatory Compliance: Our experts ensure your technical file complies with all relevant regulations and standards, such as the EU Medical Device Regulation (MDR), FDA requirements, and ISO standards. We stay updated on regulatory changes to ensure your documentation remains compliant.
- Clinical Evaluation Reports (CER): We develop comprehensive Clinical Evaluation Reports that demonstrate the safety and performance of your medical devices, supported by clinical data and literature reviews.
- Risk Management Documentation: Our team creates detailed risk management files, including risk assessments and mitigation strategies, to demonstrate your commitment to safety and compliance with ISO 14971.
- Labeling and Instructions for Use (IFU): We ensure that your labeling and IFUs are clear, accurate, and comply with regulatory requirements, providing essential information for safe and effective device use.
- Design Dossier Preparation: For high-risk devices, we prepare detailed design dossiers that provide an in-depth look at the design, development, and manufacturing processes, ensuring compliance with regulatory expectations.
- Post-Market Surveillance Plans: We develop robust post-market surveillance plans to monitor the performance of your medical devices in the market, ensuring ongoing compliance and safety.
Why us?
With extensive experience in the medical device industry and a deep understanding of regulatory requirements, our consultancy offers tailored solutions to meet your specific needs. We help you create comprehensive technical files that facilitate regulatory approval and market entry.
Partner with us to develop and maintain compliant technical files that ensure regulatory approval and market success for your medical devices. Let us guide you through the complexities of technical documentation, ensuring your products meet the highest standards of quality and safety.