MedQtech AB is a consultant company in the medical device industry. Experienced professionals with high competence who support customers in the fields of Quality and Regulatory compliance.
We have broad experience in Medical Device Industry, MDD, IVDD, ISO 13485, ISO 9001, ISO 14971, IEC 62366, IEC 62304, QSR (FDA 21 CFR Part 820, Part 11) and other regulations and standards in medical device industry.
Our mission is to provide expertise competence in the field of Quality and Regulatory Compliance and to deliver practical and sustainable solutions for our customers.
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.