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 ...

NORCROSS, GA--(Marketwired - Sep 11, 2013) - RayBiotech, Inc. announced today that the company has been awarded ISO 13485: 2003 certification with respect to its compliance in the manufacture of in ...

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 ...

SAN DIEGO, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (BIOR) (Nasdaq: BIOR), the biotech company reimagining therapeutic delivery, today announced it has been awarded ISO 13485:2016 ...

Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...

NASHUA, N.H., July 27, 2011 /PRNewswire/ -- Mass Design Incorporated has been awarded ISO 13485:2003 certification by the International Standards Organization (ISO), enhancing this printed circuit ...

PERKASIE, Pa.--(BUSINESS WIRE)--US BioDesign, a global leader in the production of biomedical textile structure components today announced that they have received their ISO 13485:2003 Certification.