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.