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Iso 13485 Medical Articles & Analysis

5 news found

Hyalex Receives ISO 13485 Certification

Hyalex Receives ISO 13485 Certification

We are happy to announce that Hyalex Orthopaedics has received ISO 13485:2016 certification for Medical Device and Quality Management Systems. ...

ByHyalex Orthopaedics, Inc.


Optim LLC celebrates 50 Year Anniversary of Optical Imaging Excellence

Optim LLC celebrates 50 Year Anniversary of Optical Imaging Excellence

With the acquisition in 1996 of Schott Fiber Optics’ flexible endoscope division, medical and industrial endoscopes were added to the product portfolio. ...

ByOptim LLC


Learn About Computrol’s Rapid Prototyping Capability at APEX

Maintaining this focus enables the company to provide faster assembly operations than those in large factories. Computrol maintains its ISO 9001-2008 certification, ISO 13485 specific to medical device quality systems, AS9100 specific to military and aerospace quality systems, IPC class II and III and J-Std certified as well as ...

ByCreation Technologies


Biomatlante receives MDSAP Accreditation

Biomatlante receives MDSAP Accreditation

Biomatlante, a world leader in synthetic bone regeneration technologies, is pleased to announce the obtention of the MDSAP* accreditation on the new ISO 13485:2016 Certificate. The Medical Device Single Audit Program (MDSAP) is an international program for assessing the quality management systems of medical device manufacturers ...

ByBiomatlante SAS


SteriLux has received ISO 13485:2016 certification

SteriLux has received ISO 13485:2016 certification

We are excited to announce that SteriLux has received ISO 13485:2016 certification for Medical Device and Quality Management Systems from Lloyd’s Register. This ISO certification indicates that the company’s quality management system meets the most current regulatory requirements specific to the ...

BySteriLux SA

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