We have now completed our transition to ISO 13485:2016 and gained recertification.
The EU Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR) requires manufacturers to be complaint by May 26 2020. Designing a medical device or IVD under a ISO1385:2016 quality management system supports the legal manufacturers overall compliance to this regulation for the device.
For more information on how eg technology can support your product design and development please contact us
Via email on design@egtechnology.co.uk, by giving us a call on +44 01223 813184, or by clicking here.
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