CE Marking

We have Experienced and Enthusiastic Professionals that help your Organization to get CE Certificates for your Devices as per EU Directives in Shortest Possible Time and Cost-effective Way.

  • CE Marking for Medical Devices For Class I, Is, Im, IIa, IIb and III as per (Directive 93/42/EEC as amended 2007/47/EC)
  • CE Marking for In-Vitro Diagnostic Medical Devices as per (Directive 98/79/EC)

Transition EU MDR

  • MDR 2017-745. Medical Devices
    (on Medical Devices, Amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and Repealing Council Directives 90/385/EEC and 93/42/EEC)
  • IVDR 2017-746 In-vitro Diagnostic Medical Devices
  • (on in Vitro Diagnostic Medical Devices and Repealing Directive 98/79/EC and Commission Decision 2010/227/EU ).

Our professionals help you in

  • Designing Your Organization Infrastructure that Complies as per EU Directive.
  • Developing Complete Documentation Procedures.
  • Assisting in Preparation of Technical Document for your Device.
  • Identifying Tests required for your Device
  • Assisting in Finalization of EU Representative.
  • Assisting in Selection of Appropriate Notified Body.
  • Assisting in Getting CE certificate. Ask for quotation...