The medical device sector must meet stringent regulatory requirements plus convince potential customers that they make reliable, safe products. Having a strong commitment to quality can help customers ...

This Certification Evidences that RevBio is Implementing the Capabilities and Infrastructure Necessary for the Commercialization of its Platform of TETRANITE® Products LOWELL, Mass.--(BUSINESS ...

Profusa received a positive decision from GMED on ISO 13485 certification, expected in early October, while additional European MDR conformity assessment work remains before the Lumee Oxygen Platform ...

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Company is among the first in China's drug-device combination products sector to obtain this certification, delivering superior solutions to global clients Zero non-conformities demonstrates company's ...

The Performance Plastics/Consumer Essential Markets (CEM) business of Trinseo (Berwyn, PA), a manufacturer of plastics, latex binders and synthetic rubber, announced that it has received ISO 13485 ...

TEMECULA, Calif., Sept. 25, 2023 /PRNewswire/ -- Rev.1 Engineering, a medical device design and development company, announced that they received the ISO 13485:2016 certification for its quality ...

The ISO 13485:2016 certification confirms Senzo as a leading provider of in vitro diagnostic device development, as it brings its Amplified Lateral Flow (ALF) technology to market PHILADELPHIA, ...

Lithoz, a ceramic 3D printing company headquartered in Vienna, has secured ISO 13485 certification for its quality management system, aligning its operations with international standards for medical ...