Quality management system standards are a great tool for organizations wanting to plan an effective and efficient quality management system. ISO 13485, the ISO standard for medical device quality ...

In a recent press release, Healthmark Industries announced that they have received ISO 13485:2016 certification. ISO 13485:2016 is designed to support medical device manufacturers in designing quality ...

Following the new outcome meeting statement posted Monday by the management committee of the International Medical Device Regulators Forum (IMDRF), Focus obtained insights into upcoming revisions to ...

Accumold secures ISO 13485 recertification, reinforcing its commitment to precision, quality, and reliability in micro molded components for demanding medical device applications worldwide.

LISLE, Ill., Oct. 2, 2025 /PRNewswire/ -- Ontogen Medtech, a leading provider of design and manufacturing services for the medical device industry, is proud to announce that it has achieved ISO ...

Cairn Surgical Inc., which is developing technology designed to make breast cancer surgery more precise, has received ISO 13485:2016 certification for the quality management system associated with the ...

BOULDER, Colo., Aug. 26, 2025 /PRNewswire/ -- Boulder Sterilization, part of the Boulder BioMed family, has received 13485:2016 certification from the British Standards Institute (BSI) for its ...

Bayer proudly announces its achievement of the ISO 13485 certification. This a globally recognised standard for quality management in the medical device industry. ISO 13485:2016 is the global ...

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 ...

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Akoya Biosciences, Inc., The Spatial Biology Company®, today announced that the company received ISO 13485:2016 certification for the design, development, ...

Asuragen, Inc., today announced that it has received ISO 13485 and 9001 certification for the quality management system for its medical devices. Asuragen undertook the more rigorous medical device ...