Medical Device Certification Services In USA
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by STEMartbased in 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 ...
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based in 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 ...
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by NSAI Inc.based in 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 ...
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