The CCG has joined a new network of working groups entitled MDevNet: Rede Nacional de Transferência de Conhecimento de Dispositivos Médicos, through its applied research domain Perception, Interaction and Usability (PIU).
MDevNet network: goals and members
The MDevNet project aims to value the knowledge developed by entities of the R & I system on technology-based medical devices through effective technology transfer processes for the industry.
In this way, professionals and researchers in the field of medical devices are joining the network aiming to create a manual of good practice for the certification of this type of device, in accordance with the recently revised European regulation.
The MDevNet network consists of several members: technology transfer enhancement entities, public companies and entities, academia and end-user representatives.
CCG/PIU participation in the MDevNet network
Carlos Silva, development coordinator of the PIU domain, e Joana Vieira, and Joana Vieira, usability analyst of the same domain, are participating in the working group of this network entitled “Survey of obstacles and promotion of mechanisms interaction between the national entities participating in the co-development and co-validation of medical devices “.
With the recent renewal of the European regulation for medical devices (Regulation (EU) 2017/745), it is the aim of PIU to incorporate usability practices into the device certification process by its manufacturers. It should be noted that the medical device certification process, in Europe and in the US, require the submission of usability test results to actual users.
Both CCG representatives in this working group have experience in this certification process, as well as fundamental research (Paterson Project) and applied in the area of medical devices (human factors, new taxonomies of errors, risk analysis).
The position of the CCG has been to reinforce the importance of documentation of past occurrences, and of analytical and empirical usability testing, involving healthcare professionals who will deal with these devices.