Xometry obtains ISO 13485 medical device manufacturing certification
April 7, 2022
Xometry, Inc, provider of an AI-enabled digital marketplace for on-demand manufacturing, headquartered in Gaithersburg, Maryland, USA, has obtained ISO 13485 certification that enables the company to expand the range of medical device manufacturing it offers.
Currently, Xometry works with 86% of Fortune 500 medical product and equipment companies, providing prototyping and manufacturing support. This certification is expected to further broaden its reach.
ISO 13485 is used to implement and maintain an effective quality management system within the medical device manufacturing industry. Achieving this certification offers improvement in internal operations while further satisfying customer safety requirements and improving competitive advantage.
The standard has become one of the most widely used QMS standards in the medical device manufacturing industry and is mandatory in some countries. ISO 13485 forms the basis for quality management system requirements in Japan, Canada, the European Union, and various other medical device markets. In the United States, the FDA is planning to harmonise its own medical device QMS standards with the ISO standard.
As well as ISO 13485, the company is certified with ISO 9001 and AS9100D.