Technical documentation
Let our experts support you in planning, preparing and updating your technical documentation to help you ensure compliance with applicable regulations.
Technical documentation in the medical device industry
Technical documentation refers to the documentation required for each medical device to ensure applicable safety and performance requirements are met. European MDR and IVDR provide an overview of required documentation in Annexes II and III. Applicable standards and guidance documents suggest methods on how to fulfill these requirements. Other markets also provide information on the required documentation directly in regulations or in applicable guidance documents.
Our consultants have the expertise to support you with all different types of technical documentation, including:
- Biological evaluation
- Clinical evaluation
- Performance evaluation (IVDR)
- Clinical investigations
- Clinical performance studies (IVDR)
- In-house developed tests (IVDR)
- Medical electric safety
- Qualification and classification
- Requirements management
- Risk management
- Software
- Usability engineering
We provide custom services to support you with your technical documentation, based on your specific needs.
- Gap analysis of your current technical documentation
- For new products/projects, supporting you in planning the set of required documentation.
- Supporting in the creation of all technical documentation
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Expert support in planning, preparing and updating your technical documentation to help you ensure compliance with applicable regulations.
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