Which data/documents must a developer of medical products/equipment provide to a Notified Body?

The new regulations for medical devices require that a medical device can be handled and used safely throughout its entire lifespan. But how does that translate to individual components or materials?

In the presentation of Unitron Regulatory It discusses in detail what information a designer should pay attention to when selecting components or materials and what information a supplier must provide to ensure that his components or materials may be used in medical applications. It also describes what information is required in each life cycle phase of medical devices and how this continues in the supply chain. Read more…

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