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Technical documentation of medical devices and IVDs

Preparation of the technical documentation

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Preparation of the technical documentation

Get tailored guidance to prepare and maintain technical documentation for your medical devices or IVDs, ensuring compliance with the Medical Devices Regulation or the IVD Regulation.

Working closely with your team, our experts will handle all aspects of documentation preparation outlined in Annex II of the relevant Regulation. We’ll streamline your existing data and information, presenting it in a clear, organized, and, whenever possible, indisputable manner.

Our goal is to make sure your documentation meets Regulation standards. This means we’ll ensure it is easily accessible, allowing your team to update it effortlessly. Plus, it will be readily reviewable by Notified Bodies and Competent Authorities. Navigate regulatory requirements with confidence, knowing your documentation is accurate, accessible, and compliant.

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