TÜV Rheinland AG

Active Implantable Medical Devices

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High-quality, active implantable medical devices, such as pacemakers or cochlear implants, give patients new quality of life. EU Directive 90/385/EEC defines the requirements for active implantable medical devices on the European market. As a notified body, we conduct conformity assessments for your active implants.

Depending on your needs, we can:

  • Evaluate your product design and audit your quality management system
  • (Annex 2).
  • Conduct an EC type examination and review quality assurance in the
  • manufacturing stage (Annex 3).
  • Perform EC verification (Annex 4).

Benefits at a Glance

With product tests and certifications from TÜV Rheinland, you:

  • Meet all the necessary requirements for launching your products on the EU market
  • Boost your customers' confidence in the quality and reliability of your active implants
  • Benefit from fast lead times and our years of experience

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