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Iso 13485 Medical Services In North America
4 services found
by:NSAI Inc. based inNashua, NEW HAMPSHIRE (USA)
ISO 13485 is a necessary certification for medical device manufacturers. It proves that you have a quality manufacturing process and the management standards in place to maintain high quality. ISO 13485 certification is the first step towards achieving compliance with European, Canadian and other regulatory ...
Manufactured by:Domico Med-Device based inFenton, MICHIGAN (USA)
As an FDA-registered and ISO 13485:2016 certified medical device manufacturer, we manufacture products that meet all specifications and relevant regulatory requirements. Thanks to rigorous quality management throughout our manufacturing process, we build medical products that work as intended time and time ...
Manufactured by:KSL Biomedical based inBuffalo, NEW YORK (USA)
KSL CRO Services team are well versed in quality compliance including requirements from ISO 13485:2016, 21 CFR Part 820 Quality System Regulation (QSR) and In Vitro Diagnostic Regulation (IVDR). KSL's team provides quality compliance services for start-ups and well-established companies looking to build out Quality Management System (QMS), maintain and improve ...
Manufactured by:Pivot International based inLenexa, KANSAS (USA)
As a cornerstone of modern business strategy, contract manufacturing fuels the success of companies across a range of sectors – including medical, industrial, agriculture, sports & entertainment, and security, to name a few. Pivot International is a global leader in the contract manufacturing industry, with over 50 years of experience. We offer unparalleled expertise and complete ...