The course is designed for professionals involved in quality management, regulatory affairs, product development, or the implementation and maintenance of Quality Management Systems in the medical device sector, as well as anyone who wishes to gain knowledge about the requirements of ISO 13485 and its practical application.

All training sessions and supporting materials will be delivered in English. 

The training aims to provide participants with the knowledge and skills necessary to understand the requirements of ISO 13485 and apply that knowledge in the implementation and maintenance of a Quality Management System (QMS) for medical devices. Participants will gain an understanding of the principles of Quality Management Systems for medical devices, learn how to apply the key requirements of ISO 13485, integrate risk management throughout the product lifecycle, and understand the fundamentals of internal auditing and continuous improvement.

The course comprises a total of 21 hours, including 9 hours of live online training and 12 hours of independent study and assessments. Live sessions will take place on 13, 15, 20, 22, 27, and 29 October, from 10:00 to 11:30 (WEST).

The programme is organised into three modules. The first module covers the fundamentals of the Quality Management System. The second focuses on Risk, Planning, and Development. The third addresses Purchasing, Production, and Performance Monitoring. The programme also includes dedicated sessions for questions and knowledge consolidation.

The training will be delivered by Inês Urbano and Marta Martins, Regulatory Affairs and Quality Consultants for Medical Devices at IPN. Both have extensive experience in the implementation and maintenance of Quality Management Systems, technical documentation, and regulatory compliance, supporting medical device manufacturers throughout the entire product lifecycle and helping them implement solutions aligned with applicable regulatory requirements.

IPN is a training provider certified by DGERT (2376/2016). To obtain the Professional Training Certificate issued through the SIGO platform, participants must attend at least 7.5 of the 9 hours of live online training and achieve a final grade of at least 10 out of 20. Participants who do not meet these requirements will receive a Certificate of Attendance.

Applications are open until 4 October 2026 and can be submitted through the online registration form here.

The participation fee is €408 + VAT (at the applicable legal rate) for registrations completed by 13 September 2026 (early bird) and €480 + VAT (at the applicable legal rate) for registrations submitted by 4 October 2026. 

Companies incubated or accelerated by IPN, IPN HealthProof clients, and organisations registering two or more participants are eligible for a 15% discount during both registration periods. Discounts cannot be combined.

For further information, interested participants may contact IPN by telephone at +351 239 700 904 / 962 or by email at formacao@ipn.pt. formacao@ipn.pt.

Consult the full programme via this link.