Do you need help in getting started to work with the new medical device regulation MDR 2017/745 or IVDR 2017/746 in Europe?
Are you ready to meet the requirements of ISO 13485:2016 or do you need a Senior Lead Auditor to perform an Internal Audit on your Quality Management System?
Do you need support in your Risk Management Process or perhaps it is time for customized education with your company? We are experts in ISO 14971.
Do you need support in the regulatory registration process for your Medical Device? We can help.
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Our mission is to provide our competence in the field of Quality and Regulatory Compliance and to offer practical and sustainable solutions for our customers, to continuously meet the regulatory requirements in the EU as well as USA.
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