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quality management systems

We provide complete support in quality management system (QMS) consulting according to the client’s special business needs in the medical device and IVD industry. By accessing a global network of our partners in several countries all over the world, MT Promedt Consulting provides regulatory services accross the lifecycle of medical devices and IVDs.

  • implementation of QMS acc. to EN ISO 13485, EN ISO 9001
  • implementation of corrective and preventive action CAPA process
  • compliance audits (internal, supplier, product and process audits)

We also offer a wide range of other services with regard to the EU Regulations MDR 2017/745 and IVDR 2017/746.

Additional services

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MT Promedt Consulting offers a complete consultancy service for medical device manufacturers. Your business is our business. So whether you need first ideas or a second opinion: we’re here to listen – and ready to answer.

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