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Medical Device Certification Services In Usa
5 services found
by:STEMart based inShirley, CALIFORNIA (USA)
CE marking is the manufacturer's declaration that their product complies technically and administratively with the essential regulatory requirements of Medical Device Directive 93/42/EEC (MDD) and its supplementary Directive 2007/47/EEC, Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) and In Vitro Diagnostics Directive (IVDD) 98/79/EC, which outline the safety and performance ...
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 ...
Manufactured by:Medisurge based inGrand Rapids, MICHIGAN (USA)
The medical devices we make have the potential to change patients’ lives. We take that responsibility very seriously. That’s why we’re ISO 13485:2016 certified and FDA Registered. We also hold a Japan Foreign Medical Device Manufacturing certificate. With MediSurge, you know your ...
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 ...
Manufactured by:Double Black Imaging based inLouisville, COLORADO (USA)
The engineers at Double Black Imaging combine years of experience with technical competency and industry expertise to develop the perfect medical imaging workstation solutions for healthcare facility partners. Providing a wide array of medical LCD monitor servicing options, the team develops recommendations based on industry best practices and insider-knowledge for PACS, Mammography/Tomo, ...