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
Technical-regulatory support for electromedical device & medical software:
- Gap Analysis - Design and development process
- Gap Analysis - Requirements
- Gap Analysis - Cybersecurity
Usability testing
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)

70 Companies supported
Regulatory training to over 300 individuals
More than 150 medical devices and in vitro diagnostics medical devices products placed on the market with CE marking and/or FDA process