Technical File Elaboration

Expert Technical File Elaboration Services for EU MDR Compliance for Medical Devices

Ensure your medical devices meet MDR 2017/745 compliance with our expert Technical File elaboration service. This critical dossier is essential for market approval, detailing all necessary documentation and evidence that your medical device adheres to stringent regulatory standards.

Our comprehensive service covers every aspect of Technical File preparation. We guide you through compiling detailed information about your device, including its design, intended use, and manufacturing processes. Additionally, we help document the risk management processes and clinical evaluations, ensuring everything complies with MDR 2017/745 requirements.

We also assist in preparing essential elements like the Declaration of Conformity, and support to find suitable test laboratories. Moreover, we ensure that all labeling and instructions for use are clearly documented. This meticulous documentation not only facilitates smoother regulatory reviews but also enhances product safety and market readiness.

Our team of regulatory experts simplifies this complex process, making it accessible and manageable for you. We focus on creating a robust Technical File that stands up to regulatory scrutiny, thus avoiding potential delays and non-compliance issues. By choosing our service, you gain a partner dedicated to ensuring your medical device’s successful market entry.

In summary, our Technical File elaboration service provides the expertise and support you need to navigate the regulatory landscape efficiently. Let us help you compile a comprehensive, compliant Technical File, ensuring your medical device meets all MDR 2017/745 standards and reaches the market seamlessly.

Why do you need this service?

We support in setting up a compliant and robust technical file that fulfills all requirements of the MDR 2017/745 Annex II. You have already a technical file but needs an update? We are here to help.

You have difficulties to identify which general safety and performance requirements are applicable? Leave it with us. Our experts will guide step by step.

Your product is already on the market. Do you know which post market requirements need to be met? Don’t worry. We support with the proper planning and define the most appropriate post market reporting. This ensures your technical file will stay up-to-date.

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