Medical device companies, listen up. There is zero excuse for not complying with medical device quality system regulations. FDA has published and makes available ALL regulations required for medical ...
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 ...
Dublin, Feb. 13, 2025 (GLOBE NEWSWIRE) -- The "An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Training Course" conference has been added to ResearchAndMarkets ...
The new certification is in addition to the ISO 13485 certifications the company has had for engineering since 2009 and manufacturing since 2007 and is a testament to its expertise in developing ...
What is ISO 13458? This is the easy part; ISO 13485 specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical device ...
This seminar offers medical device manufacturers the opportunity to enhance efficiency and compliance by applying Lean Documentation and Lean Configuration principles. Led by expert Jose Mora, it ...
Hsinchu, Taiwan, Oct. 25, 2017 – The leading custom ASIC company, Global Unichip Corp. (GUC), today announced the achievement of highly coveted ISO 13485:2016 certification, which make GUC the first ...
DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Statistical Process Control" conference to their offering. This two-day workshop provides the information you need to ...
Design Controls are defined in FDA 21 CFR 820.30 and in section 7.3 of ISO 13485. Design Controls are a systematic framework for capturing key aspects of medical device product development to prove ...
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