Other Useful Medical Device Industry Links

Medical Device QA & RA Consulting - Emergo Group specializes in providing quality assurance and regulatory affairs consulting services to medical device and IVD companies.

FDA 510(k) Preparation - Providing help for medical device companies that want to file a 510(k) application with the US FDA to obtain clearance for a new device to be sold in the USA.

ISO 13485 Consulting and Implementation - Emergo Group helps medical device companies implement ISO 13485 and also offers training and employee training services.

European Authorized Representative (EC REP) - Provides EU-required regulatory representation to medical device companies with no physical location in Europe.

Green Dot packaging waste management - Company helps medical device and pharmaceutical companies comply with the European Packaging Waste Directive.

薬事コンサルティングサービスのご案内 - Emergo Japan K.K. provides Japanese clients with regulatory consulting support.

Consultants Internationaux en Dispositifs Medicaux - Emergo France provides French QA and RA consulting services from its office in Paris.