CE Certification Consulting

We support in compiling your technical file or design dossier as per the requirements of Europe’s CE certification process including as per the Medical Devices Directive 93/42/EEC. In Vitro Diagnostic Medical Devices Directive 98/79/EC, or Active Implantable Medical Devices Directive 90/385/EEC. In case of Class of IIa, IIb and Class III devices a more complex CE Technical File or Design dossier shall be prepared. If the medical device is Class I with measuring or sterile function, Class IIa, IIb, and III, the Technical File will be review by a Notified Body. An incomplete or improperly completed Technical File may result in unexpected delays or even prevent market entry. We support in the preparation/review of technical files and  in every step of CE marking to ensure its compliance to the required standard.