Certification of quality management systems

Approvals are indispensable, and a certified quality management system is a basic requirement for success and furthermore a good marketing instrument for manufacturers of medical devices. ecm assists its clients on both routes in acquiring the requisite certificates as quickly as possible. ecm provides the certification of quality management systems in accordance with EN ISO 13485 and related standards, such as EN ISO 9001 or EN ISO 15378. In a dialogue with us, you will find out which certificates, if not compulsory, are still expected by your customers, or which are absolutely essential in certain countries to open the door to the market for your product.

ecm’s services as a certification authority are provided in the following sectors:

  • non-active medical devices
  • medical devices in sterile condition or with low microbial count

In the active medical product sector, we also certify the maintenance and servicing of active equipment.