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MEDICAL DEVICES REGULATORY UNIT

The Instituto Pedro Nunes (IPN), through the Laboratory for Automation and Systems (LAS), is able to support companies and institutions in the process of certification of Medical Devices and Medical Devices in vitro. Through the identified needs, IPN supports your company/ institution through personalized service.

We offer services in the following areas:

  • Implementation of the new European Regulation requirements for Medical Devices - Regulation UE 2017/745
  • Implementation of the new European Regulation requirements for in vitro Medical Devices - Regulation UE 2017/746
  • Support in the UDI (Unique Device Identification) process
  • Support in the registration in the EUDAMED platform
  • Support in the CE Marking process
  • Support in the ANVISA process
  • Support in the FDA proces
  • Support in the UK process
  • Implementation / update of the ISO 13485 and ISO 9001
  • Internal audits of the Quality Management System and/ or the product
In addition to the services listed, we have other solutions at your disposal within this theme, for more information contact us via email medicaldevices@ipn.pt.

Indicators (last 2 years)

  • 42 Companies supported
  • 9 Training courses nd webinars
  • More than a hundred products placed on the market with CE marking according to the new EU Regulation 2017/745

Coordination


Contacts

medicaldevices@ipn.pt | +351 239 700 933

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