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EU Authorised Representative Medtech

As your trusted partner and EU Authorised Representative Asphalion will guide you to comply with European regulations for Medical Devices and IVD

As your trusted partner and EU Authorised Representative Asphalion will guide you to comply with European regulations for Medical Devices and IVD

We can offer you the following services:

  • Contact point with EU Competent Authorities and Notified Bodies
  • Support with Medical Device and IVDs registrations, as required
  • Keeping Technical Documentation and Declaration of conformity available upon Health Authorities request
  • Regulatory intelligence: stay always up to date on legislation changes and how they can affect your products

 

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EU Authorised Representative Medtech

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May 11, 2023
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| By Asphalion
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