Technical Files & Design Dossiers

The Importance of Technical Files and Design Dossiers

A Technical File or Design Dossier is a comprehensive set of documents that demonstrate your medical device’s compliance with the relevant regulatory requirements, such as the EU MDR or IVDR. This documentation must provide evidence of the device's design, manufacturing processes, risk management, and clinical data.

Our team assists you in the compilation, review, and maintenance of your technical documentation, ensuring that it meets the rigorous standards expected by Notified Bodies and regulatory authorities.

Our Technical File Services Include:

  1. Device Description and Specifications: This section includes a detailed description of the device, its intended use, and its classification. We ensure that all device specifications, including technical features, materials, and components, are thoroughly documented.
  2. Design and Manufacturing Information: We help document the design and manufacturing processes, including the manufacturing facility and processes involved.
  3. Risk Management: Compliance with ISO 14971 is essential. We assist in developing a comprehensive risk management plan to ensure potential risks throughout the product lifecycle are identified and addressed.
  4. Clinical Evaluation and Evidence: Depending on device classification, a Clinical Evaluation Report (CER) may be required to demonstrate safety and effectiveness.
  5. Performance and Safety Testing: We ensure that relevant testing (e.g., biocompatibility, electrical safety, sterility) is properly documented and included.

Why Accurate Technical Documentation is Critical

  • Expertise in Regulatory Requirements: Our team has in-depth knowledge of regulatory requirements across multiple regions.
  • Efficient Process: Our streamlined approach ensures you save time while maintaining compliance.

Let us help you prepare a compliant, thorough, and efficient Technical File that meets regulatory requirements, accelerates market access, and supports the long-term success of your medical device.