LAS

Services

Medical Devices Regulatory Unit

IPN, through its Automation and Systems Laboratory (LAS), is qualified to support your organisation in the certification process for Medical Devices and In Vitro Medical Devices. Based on the needs identified, IPN supports your organisation through a personalised service.

We offer services in the following areas

European Companies

  • Support in implementing the requirements of the new European Regulation applicable to Medical Devices – EU Regulation 2017/745
  • Support in implementing the requirements of the new European Regulation applicable to in vitro medical devices – EU Regulation 2017/746
  • Support in the UDI (Unique Device Identification) process
  • Support with registration on the EUDAMED platform
  • Support in the CE Marking process
  • Support in the ANVISA process
  • Apoio no processo FDA
  • Apoio no processo UK
  • Support in implementing/updating ISO 13485 and ISO 9001
  • Apoio técnico-regulamentar para dispositivo eletromédico & software médico:
    • Gap Analysis – Processo de design e desenvolvimento
    • Gap Analysis – Requisitos
    • Gap Analysis – Cibersegurança
  • Usability testing
  • Internal audits of the system and/or product

 

Brazilian Companies
For Brazilian companies interested in exporting their medical or in vitro diagnostic products to the European market, we provide the following services:

  • Support in the European CE process
  • Support in issuing the Declaration of Conformity
  • Support in the Clinical Assessment process
  • Support in conducting clinical trials
  • Support in the Post-Market Monitoring process
  • Support in applying for a notified body
  • Support in appointing a European Representative for Regulatory Compliance (PRRC)
  • Support in using the Eudamed platform
  • Apoio técnico-regulamentar para dispositivo eletromédico & software médico:
    • Gap Analysis – Processo de design e desenvolvimento
    • Gap Analysis – Requisitos
    • Gap Analysis – Cibersegurança

In addition to the services listed, we offer other solutions in this area, namely support for the development of medical devices. For further information, please contact us by email. medicaldevices@ipn.pt.

Indicators (last 2 years)

  • 70 Companies supported
  • Over 300 participants benefited from training in the regulatory area
  • Over 150 medical devices and in vitro diagnostic medical devices placed on the market with CE marking and/or FDA process

Coordination

Ana Brito

medicaldevices@ipn.pt | +351 239 700 933