Technical File Elaboration

Sobel Consultancy proudly presents the invaluable service of Technical File Elaboration. This service meticulously compiles technical documentation in complete alignment with annex II of the MDR 2017/745, ensuring your business remains in compliance and thrives in regulatory-heavy industries. The process of creating a comprehensive medical device technical file is complex and often daunting. With Sobel's unmatched expertise, this intricate task is transformed into a streamlined, efficient process. Your CE file is handled by seasoned professionals who understand your industry's nuances and regulatory requirements. Trust Sobel Consultancy to deliver accurate, comprehensive, and timely medical device documentation that acts as a pillar of support for your business, fostering credibility and reliability.

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.

Looking for technical file assistance?

Are you a medical device manufacturer looking to comply with the EU Medical Device Regulation 2017/745? Take action now and ensure the smooth functioning of your business by availing our service for technical file elaboration. Let us guide you through the process and provide you with the necessary documentation to meet regulatory requirements.

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