Outsourcing your ISO13485 Quality Management system?

quality management systems for medical devices

A growing number of organizations are challenged with keeping up with their quality management system for medical devices. Over the last few months we have received multiple questions within our network whether we can maintain the implemented quality management system. This question often relates to a quality management system in accordance with the ISO 13485 standard for medical devices.  Organizations tend to have an internal quality manager who supervises the complete quality management system.

However, it often occurs that the position of quality manager cannot be fulfilled internally due to divergent circumstances. In those cases it is possible to outsource the activities of a quality manager to CE Medical. CE Medical offers the service which facilitate maintenance of quality management systems, tailored to the needs of our clients. With this service, the quality management system will be maintained by CE Medical.

As organizations do not require to employ a full-time quality manager, this service also has benefits specifically from a financial point of view. A small grasp of other advantages of this service are as follows.

  • One contact person to answer all your quality management questions.
  • Complete unburdening of the quality management.
  • Your contact person can be reached throughout the workweek.
  • Flexibility in working hours. It could occur that more hours can be spent in one week, while less hours are required in the following week.
  • The contact person is a BSI certified ISO 13485:2016 lead auditor.

Are you interested in outsourcing the maintenance of your ISO 13485 quality management system? Do not hesitate to contact CE Medical via telephone (+31 (0)294 41 75 81) or e-mail (info@ce-mark-medical.com) to discuss the possibilities.

Would you like to know more about this subject? Or do you have other questions about CE marking? Please contact us today!