In-house Devices

In-house devices can be used in health institution without having to comply with most of regulatory provisions of EU MDR or EU IVDR…….

In-house IVDs

What are in-house IVDs? What are the new requirements and timelines under EU IVDR and Swiss IvDO for in-house IVDs?

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Clinical trials in Switzerland

Categorize the clinical trial according to Swiss ClinO-MD must be the very first step towards the planning of clinical trial in Switzerland

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Compliance activities for legacy IVDs

How manufacturers and importer can safely and smoothly navigate through the IVDR transitional period for IVDD-certified devices......

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A look into Swiss clinical trial

Sponsors planning to conduct clinical trials for medical devices in Switzerland or multi-centre clinical trials including Swiss investigational sites should be aware of the changes .....

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