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Iso 13485 2016 Medical Devices Services In North America
7 services found
Manufactured by:SHL Medical AG based inZug, SWITZERLAND
SHL implements quality management systems throughout all phases of development and production to ensure consistency in all products. SHL’s quality system complies with FDA Quality System Regulation, Medical Device Regulation, and ISO 13485:2016. The system is regularly audited by customers and monitored ...
Manufactured by:Myriad Fiber Imaging Tech Inc. based inDudley, MASSACHUSETTS (USA)
The team at Myriad brings extensive expertise in the design, development, and manufacturing of medical devices, including ISO 13485 design controls and the ability to create a full DHF to support the regulatory filing process. Myriad has supported the Research & Development community for years by providing assemblies and sub-assemblies designed for production. We work closely with large Med ...
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 ...
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), ...
by:Bureau Veritas North America, Inc. based inNew York, NEW YORK (USA)
Meeting legislative regulations and customer requirements for the manufacture and sale of medical devices in a global marketplace can be confusing. With so many regulations, differing from country to country, an organization must address a complex array of quality, process, and management issues in order to compete ...
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 requirements for medical device ...
by:NOVO Engineering based inVista, CALIFORNIA (USA)
NOVO specializes in medical device development services for Class I, II, and III FDA-regulated devices. The scope of our ISO 13485:2016-certified quality management system (QMS) covers a five-phase product development process (PDP) from concept through manufacturing transfer, including support ...