Support for Swiss importers and distributors and dealers of MEDICAL PRODUCTS

1. Importers

We support importers in the implementation of their obligations, which they must fulfill according to the In Vitro Diagnostics Medical Devices Ordinance IvDO.

The support can take the form of consulting sessions, training, preparation of documents together with the process owners, an internal audit or according to your individual needs.

If you would like to set up or further develop your own quality management system, we are also the right people to contact.

2. Distributors

We support distributors in the implementation of their r obligations, which they have to fulfill according to the In Vitro Diagnostics Medical Devices Ordinance IvDO.

The support can take the form of consulting sessions, training, preparation of documents together with the process owners, an internal audit or according to your individual needs.

If you would like to set up or further develop your own quality management system, we are also the right people to contact.

3. Dual role of importer and trader

We support importers, who are also distributors, in the implementation of their obligations, which they have to fulfill according to the In Vitro Diagnostics Medical Devices Ordinance IvDO.

The support can take the form of consulting sessions, training, preparation of documents together with the process owners, an internal audit or according to your individual needs.

If you would like to set up or further develop your own quality management system, we are also the right people to contact.

4. Dual role of importer and Swiss Authorised Representative

We support importers, who also assume the role of the Swiss authorized representative, in the implementation of their obligations, which they must fulfill according to the In Vitro Diagnostics Medical Devices Ordinance IvDO.

The support can take the form of consulting sessions, training, preparation of documents together with the process owners, an internal audit or according to your individual needs.

We also offer you the possibility that you can use us as your "person responsible for regulatory compliancePRRC commit. Thus, on the one hand you have fulfilled an obligation and on the other hand you have permanent access to an expert.

If you would like to set up or further develop your own quality management system, we are also the right people to contact.

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Do you have questions?

We will contact you if you send us a message.

Contact us by email at ar@ch-rep.com 

You will receive prompt feedback.

What is a medical device?

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