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 ...

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 ...

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 ...

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 ...

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 ...

TDK-Lambda Japan received ISO 13485:2016 Medical Devices—Quality Management System—certification for the TDK-Lambda Nagaoka Technical Center (Nagaoka City, Niigata Prefecture, Japan). TDK-Lambda Japan ...

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 ...