The 2003 version of ISO 13485 is organized differently than the 1996 version. Much of the change is related to the prescribed process approach (as opposed to procedures or elements) and such a ...
Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
FDA has published and makes available ALL regulations required for medical device companies. Look them up by searching 21 CFR part 820. And for outside U.S., you can easily obtain ISO 13485 for a ...
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 ...
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 ...
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 ...
RUTHERFORD, N.J., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (Nasdaq: GCTK) (“Glucotrack” or the “Company”), a medical technology company focused on the design, development, and ...
Abu Dhabi, UAE: ProvenMed announces today that it has received the ISO 13485:2016 certification for Medical Device and Quality Management Systems for its innovative Med-Tech solutions. “We are ...
FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...
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 ...
SEATTLE--(BUSINESS WIRE)--Kubota Vision Inc. (“Kubota Vision” or the “Company”), a clinical-stage specialty ophthalmology company and a wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., ...
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