European market access with a trusted CE Marking Notified Body. Accessing the European market brings challenges that can lead to delays in your product launch. Such delays can be costly for the manufacturer, and for patients who require care. However, there are stringent requirements in place to ensure ...
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 ...
By STEMart based in Shirley, CALIFORNIA (USA). from Medical Device Development Service - Medical Device Certification Services Service line
MicroFrance instruments meet European regulatory requirements for medical devices, materialised by the affixing of the CE marking. Furthermore, we have NF EN ISO 13485:2016 and MDSAP for the activities of design, manufacturing, inspection, and marketing of active and non-active instruments, including ...
By Integra MicroFrance based in FRANCE.
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