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Audit & Governance

Audit & Governance is a Swiss company actively involved in the development of strategies for product certification and quality management systems. For over 20 years A&G professionals have been assisting companies in medical devices certification, in their classification and in the training of regulatory affairs.

We can assist you during the whole development of the certification process of the medical device or of your quality system with a customized service designed to respond in a concrete and effective way to your real needs.

Improving knowledge, awareness and competence is more than a goal, it is our mission!

We can assist you during the whole development of the certification process of the medical device or of your quality system with a customized service designed to respond in a concrete and effective way to your real needs.

Improving knowledge, awareness and competence is more than a goal, it is our mission!

To date, Audit & Governance has successfully completed and in the time scheduled the 100% of the projects entrusted thanks to the preventive assessment that we carry out and which allows us to identify our strengths and weaknesses in advance.

 

The transition period between the current Medical Device Directive 93/42/EEC and the new Medical Device Regulation 2017/745 is a period to be used to review the clinical evaluation and availability of clinical and pre-clinical data.

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