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 ...
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 ...
This Certification Evidences that RevBio is Implementing the Capabilities and Infrastructure Necessary for the Commercialization of its Platform of TETRANITE® Products LOWELL, Mass.--(BUSINESS ...
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CLEVELAND--(BUSINESS WIRE)--KeborMed, the connected care platform, announced today it attained the ISO 13485 certification for its quality management system. This milestone marks a significant step in ...
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 ...
SAN DIEGO, Sept. 6, 2022 /PRNewswire/ -- CorDx, a global leader in the development, manufacturing, and distribution of diagnostics and medical devices, recently received EN ISO 13485 certification for ...
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 ...
JUPITER, Fla., November 14, 2022 (Newswire.com) - Alphazyme, a manufacturer of molecular biology enzymes, has been awarded certification to the ISO 13485:2016 Quality Management System (QMS) standard ...
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 ...
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