ISO 13485
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ISO 13485
FDA Registered
No part of this website may be reproduced or otherwise used without the express written consent of Autocam Medical.
MEDICAL DEVICE AND DIAGNOSTIC INDUSTRY: Autocam Medical’s Plymouth, MA Facility Recertified to ISO 13485:2016
/in News /byAutocam Medical, a medical contract manufacturer, has received ISO 13485:2016 recertification on its facility in Plymouth, MA. “This recertification indicates our continued investment in a quality management system which ensures process control, accurate reporting, and traceability. This approach dramatically improves manufacturing integrity, reduces lead time, and provides the most reliable and high quality medical device […]
BONEZONE: Autocam Medical’s Plymouth, MA Facility Recertified to ISO 13485:2016
/in News /byAutocam Medical’s Plymouth, Massachusetts facility has been recertified to ISO 13485:2016. The scope of the certificate is “contract manufacturer of machined non-sterile medical device components and instruments, built to customer specifications.” The facility is also certified under ISO 9001. Greg Coberly, Global Director of Quality, stated, “This recertification indicates our continued investment in a quality […]
MEDICAL DESIGN & OUTSOURCING: Autocam Medical’s Plymouth, MA Facility Recertified to ISO 13485:2016
/in News /byAutocam Medical (Kentwood, Mich.) announced that its Plymouth, Mass. facility was recently certified to ISO 13485:2016. The surgical implants, instruments and related products manufacturer showed that its quality system was effectively implemented and maintained in order to be ISO 13485 certified. “This recertification indicates our continued investment in a quality management system which ensures process […]
MASS DEVICE: Autocam Medical’s Plymouth, MA Facility Recertified to ISO 13485:2016
/in News /byNN announced that it has acquired DRT Medical from DRT Holdings. The financial details of the deal were not disclosed. NN is an industrial company that has advanced engineering and production capabilities to design and manufacture high-precision components and assemblies for a number of markets across the globe. The company has 36 facilities across North […]
QMED: Autocam Medical’s Plymouth, MA Facility Recertified to ISO 13485:2016
/in News /byAutocam Medical, a global contract manufacturer of surgical implants, instruments and related products, has announced its Plymouth, MA facility has been recertified to ISO 13485:2016. ISO 13485 requires that the certified organization demonstrate the quality system is effectively implemented and maintained. The scope of the certificate is “contract manufacturer of machined non-sterile medical device components […]