Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
In the words of the rock band REO Speedwagon, from the 1978 song “Roll with the Changes,” “It had to happen, felt the tables turnin’.” 1 Earlier this month, the Food and Drug Administration’s Device ...
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 ...
Dublin, June 28, 2024 (GLOBE NEWSWIRE) -- The "The US FDA QMSR Transition - 21 CFR 820 and ISO 13485" training has been added to ResearchAndMarkets.com's offering. The US FDA, after years of ...
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 ...
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 ...
Certification enhances global market readiness, reinforces quality systems, and supports Zomedica's long-term growth strategy ANN ARBOR, MI / ACCESS Newswire / November 6, 2025 / Zomedica Corp. (OTCQB ...
In this two-day workshop, you will gain the knowledge and skills you need to audit your quality system to the ISO 13485:2016 standard. Course topics include updates the ISO 13485 standard, ISO ...
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