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.
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.