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We help manufacturers develop safe medical devices and bring them to market despite complex regulatory requirements, thereby providing patients with the best possible care.

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Johner Institute North America > Consulting > Technical Documentation
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Technical Document­ation

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We help you get your IVD medical devices approved quickly and safely, with complete technical documentation that complies with the law.

We meet the requirements to have your medical and IVD medical devices approved successfully in your target market. Further, we provide reliable support in preparing the required documents and files in the following areas:

Biological Safety

IT Security

Post-Market Performance Follow-up

Usability

Clinical Evaluation

IVD Performance Evaluation

Risk Management

Durability and Transport Validation

Post-Market Surveillance

Software & Medical Devices

Electrical Safety and EMC

Post-Market Clinical Follow-up

IVD Medical Devices with AI

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