CAMBRIDGE, England--(BUSINESS WIRE)--Dante Labs, a world leader in genomic sequencing and data analysis, announced today that it received ISO 13485:2016 certification for its Immensa Genomic ...
PALO ALTO, Calif., April 18, 2025--(BUSINESS WIRE)--Tidepool, a nonprofit organization dedicated to empowering the diabetes community through open-source innovation, proudly announces it has achieved ...
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, ...
DUBLIN--(BUSINESS WIRE)--The "An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Training Course (Nov 20, 2025)" training has been added to ResearchAndMarkets.com ...
This 90 minute in-depth webinar discusses the FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies, many going back to ...
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 ...