All manufacturers are now required to have a Quality Management System in place

Quality Management Service

All medical device manufacturers or ‘virtual manufacturers’ (Own Brand Labelling) are now required, under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), to have a Quality Management Service in place. This is usually in the form of applying ISO 13485:2016, which needs to be certified by an accredited certification body.

Once the Quality System is in place, it must be managed and maintained by a quality service representative who can carry out annual audits. Employing a representative to carry out the quality management service for you can be expensive, and for small companies, it’s unlikely to warrant a full-time position.

This can be subcontracted to a 3rd party on the basis of a consultant managing the system for the company on a few days per month basis. We would be happy to discuss this option with you, helping to keep your ongoing costs to a minimum.

If you would like to know more about our quality management service, then please contact us for further information.

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