2 documents found, page 1 of 1
Measurement properties of the incremental step test for people with chronic obs...
Gonçalves, T; Carlos Winck, J; Silva, F; Caneiras, C; Montes, AM; Vilarinho, RObjectives: The new incremental step test (IST) is a field test that was developed for people with chronic obstructive pulmonary disease (COPD), based on the characteristics of the incremental shuttle walk test (ISWT); however, its measurement properties still need to be determined. We aimed, first, to assess the construct validity (through the comparison with the ISWT), within-day reliability and measurement e...
Preparing the certification of software as a medical device: a european regulat...
Lopes, IE; Pinto, JF; da Silva, HP; Chambel, G; Clemente, C; Silva, DCF; Montes, AM; Simões, DPurpose: The primary objective of this study is the preparation of the certification of the Clynx® Platform, a physiotherapy software, as a Class IIa medical device software in accordance with the regulatory framework outlined in Medical Device Regulation 2017/745 (MDR). Methods: The methodology involves a comprehensive analysis of European Union medical device regulations and guidelines, with a specific focus ...