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Technical documentation of medical devices and IVDs

Technical documentation Gap Analysis

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Technical documentation Gap Analysis

Tap into our experience to conduct a comprehensive Gap analysis of your medical device or IVD technical documentation, ensuring it aligns with the latest EU Regulations, 2017/745 and 746, replacing the Medical Devices Directive or the IVD Directive. Get our support to understand if your current technical documentation, drafted under previous directives, meets the updated EU Regulations. If not, we identify the necessary adjustments required to ensure compliance.

This service is invaluable for all organizations manufacturing medical devices or IVDs, as it ensures their products fully comply with the latest legal requirements in the industry. With our expertise, you can navigate regulatory changes confidently, ensuring your documentation meets the highest standards of compliance.

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