Designed by Surgeons for Surgeons, for Clinical Follow-up and Evaluation of Joint Arthroplasty in Orthopaedics, this software suite has been able, over technological progress and the evolution of clinical “evidence-based Medicine” requirements, to offer a powerful and optimized tool for today’s requirements. The Medical Device Regulation (MDR) will come into force in May 2021… See how we can help you !
The current imperatives of a “modern” assessment as now framed by regulatory provisions at European level, and meeting strict ODEP-type criteria via the EFORT institutions, are resolutely oriented towards a new generation of IT tools for clinical data collection… On the one hand, it is a matter of optimizing the capture of clinical data by significantly reducing administrative work and financial burdens, and on the other hand, creating exhaustive, reliable registers via an automatic collection of the annual status of each implant in the long term. These requirements are perfectly defined by the legal framework of these new regulations for medical devices, specifying that these so-called “MDR” (Medical Devices Regulation) provisions, initially planned for this year 2020, will not be effective due to the health crisis until spring 2021 …
This is how three major features of OrthoWave are currently available: (1) Three distinct data entry modes in addition to the classic “academic” version, supplemented by two entry modes on smartphones, ”, namely on the one hand, a “REG” version intended for epidemiological data and status of implants for registers, and, on the other hand, the “OBS” version selecting the observational data useful and necessary for conventional monitoring such as the preparation of MDR-type regulatory files, or the writing of scientific articles. (2) • The “connected patient” has become the rule for this version 7, and especially finds its interest with the AMS procedure of sending fully automatic questionnaires, completely discharging the medical secretary, and allowing a real exhaustiveness of the clinical follow-up and the status of each implant in the long term, and finally (3) the OWOS-10 questionnaire allows for assessing the status of each implant over the years, which is the essential key to any exhaustive register.
This new version 7 of the OrthoWave software suite, after constant evolution for two decades, has been developed for these objectives and should prove to be a particularly reliable tool within this “modern” generation of IT developments serving clinical evaluation of our joint implants. This multilingual software can thus be considered as the most advanced tool for monitoring and evaluation “in real time” in Orthopedics, perfectly in line with the MDR regulatory provisions, which will very soon have the force of law and will involve a new and decisive management of our medical files, both at the level of the surgeons themselves, as well as of industry players for the distribution of implantable devices in Orthopedics.