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 ...

FREMONT, Calif., Sept. 27, 2023 (GLOBE NEWSWIRE) -- Cytek Biosciences, Inc. (Nasdaq: CTKB), a leading cell analysis solutions company, today announced that it has received EN ISO 13485:2016 Quality ...

Certification to ISO 13485 extended to also include production process Supports Bentrio growth strategy together with strategic contract manufacturer and expanding network of international ...

Introduces early stage audit readiness solutions to streamline ISO 13485 certification for medical device and IVD companies inline with MDR, IVDR and FDA QMSR CHARLOTTE, NC, UNITED STATES, April 29, ...

BROCTON, N.Y.--(BUSINESS WIRE)--Jamestown Plastics, one of the most highly diversified custom plastic companies in the world, has been accredited ISO 13485:2016 (ISO 13485) certification, underscoring ...

RUTHERFORD, N.J., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (GCTK) (“Glucotrack” or the “Company”), a medical technology company focused on the design, development, and commercialization of ...

DENTON, Texas, July 2, 2025 /PRNewswire/ -- ManaMed LLC, a leading innovator in medical device solutions, proudly announces its certification to ISO 13485 by BSI®, a globally recognized standard for ...

Glucotrack, Inc., a medical technology company specializing in diabetes solutions, announced it has achieved ISO 13485:2016 certification from the British Standards Institute, marking a significant ...

Introduces early stage audit readiness solutions to streamline ISO 13485 certification for medical device and IVD companies inline with MDR, IVDR and FDA QMSR ...