Agorasaludapp – AgoraSalus
Assessment of AgoraSalus, a digital platform connecting healthcare professionals and patients, as possible medical device software (MDSW) under the MDR.
A digital communication platform between healthcare professionals and patients for post-operative follow-up: scheduled question protocols tailored to each procedure and messaging between doctor and patient.
Role of MeDev Consulting: Assessment of the software as possible medical device software (MDSW) under Regulation (EU) 2017/745 and MDCG 2019-11 rev.1: analysis of the intended purpose and of each function in a test environment covering all four user roles, and a qualification report with a reasoned conclusion on the need for CE marking.
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The challenge
Agorasaludapp needed to know whether AgoraSalus, its digital communication platform between healthcare professionals and patients, should be considered medical device software (MDSW) under Regulation (EU) 2017/745 and, therefore, whether CE marking was required.
What we did
At MeDev Consulting we analysed the intended purpose and the claims of the platform, and assessed each function using the decision steps of MDCG 2019-11 rev.1, in a test environment with fictitious data and all four user roles.
Result
We delivered a signed qualification report to Agorasaludapp, with a reasoned conclusion on the need for CE marking and practical recommendations. The project was closed in line with the terms of the offer.