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Iso 13485 2012 Certification Services In Usa California
2 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 requirements for medical device ...
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 ...