• Technical File
  • medical devices clarification
Do you want to distribute Medical Devices to Europe?
We are here to assist you!
Online Services for MDD, IVDD & AIMDD. CE marking.
contact us

Information

  • Technical advice & consulting services
  • Medical device’s classification
  • CE certification road map
  • Testing & measurement laboratory
  • Labeling advice and IFU translations

read more

Technical File

  • Technical File preparation
  • Risk management implementation
  • Planning factory process control
  • Declarations Issue
  • Labeling and IFU translations

read more

Certification

  • Certification procedures
  • Notified Body selection & paper work
  • Support during Certification Audit
  • Guidance for closing NCs translations 

read more

loading...

Are you....?

1. Are you a Medical Devices manufacturer outside the EU, who wants to export to the EU?

 

2. Are you a Medical Devices dealer outside the EU, who wants to export to the EU?

 

3.Are you a Medical Devices manufacturer in the EU, who wants to distribute your products within the EU market?

 

4. Are you a Medical Devices dealer in the EU, who wants to import Medical Devices from countries outside the EU and distribute them within the EU?

 

5. Are you a Medical Devices manufacturer or dealer outside the EU who is looking for an EU representative?

Do you...?

1. Do you wish to distribute Medical Devices of another manufacturer under your brand name?

 

2. Do you wish to assemble Medical Devices whose parts have been manufactured outside the EU and distribute them in the EU?

 

3. Do you wish to be an OBL manufacturer of class II & class III Medical Devices whose CE Certificate by the Notified Body does not refer to the OEM

 

 

contact us