Introduce efficiency to every step of registry management
Reduce the challenges of registry management
Designing a registry requires careful and calculated effort that can strip departments of time, money, and other resources.
Registry optimization with UNITY
We provide an intuitive platform for managing your registry: efficient, customizable and interoperably applicable.
Fulfill post-market EU-MDR requirements
The EU-MDR demands siginificant amounts of long-term post-market device safety data.
The EU-Medical Device Regulation (MDR, 2017/745) aims to increase transparency and traceability at all stages of a device’s lifecycle by means of more stringent pre- and post-market demands.
Device registries represent an advantageous method for verifying the long-term safety and performance of medical devices. These repositories of patient and device data serve as a powerful tool to observe the relationship between treatment method and patient outcomes.
Annex XIV of the EU-MDR specifically includes registries as a potential source of post-market data.
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This paper contains practical implications for manufacturers and important deadlines.
Integrate electronic patient-reported outcomes (ePROs) into your registry
ePROs capture the long-term efficacy of treatments from the patient’s point of view.
ePROs can supplement long-term device data by generating a realistic depiction of patient satisfaction. Specifically in the field of orthopedics, there is increasing demand from legislators and clinicians to collect and evaluate ePROs.
Collecting and managing ePROs, however, can be an arduous administrative task that can be resolved with UNITY.
Intelligent software solution for registry management
Streamlined design and maintenance of your patient and device registry
Leverage our software expertise to help build your commitment to evidence-based medicine.
UNITY assists stakeholders in aggregating patient-reported outcomes and radiographic images over time and overcomes the limitations of traditional post-market clinical follow-up studies (PMCF) such as small patient cohorts and hospital selection bias.
Combining ePROs and AI-driven analysis of radiographic imaging data, UNITY captures the necessary data to produce a continously robust image of device efficacy and safety in post-market settings. Furthermore, it automates many of the administrative processes that complicate registry management while upholding patient data protection standards.
Additional, EU-MDR-relevant product data can also be integrated into UNITY.
How RAYLYTIC customers profit from our solutions:
The UNITY platform is easy to use and the collection of PROMs/CRFs is robust in daily use. The automatic anonymization of the uploaded image data and their statistical analysis are also extremely helpful.
PROF. MICHAEL PUTZIER
Chief Senior Physician at the Center for Musculoskeletal Surgery/Charité Berlin
UNITY facilitates getting patient data and outcome measurements to a higher level. The system is easy to use, the image upload is smooth and complete data analysis is provided quickly and thoroughly, including discussions and advice for improvement.
DR. NANCY LAMERIGTS
Former VP of Research and Marketing at Emerging Implant Technologies
The RAYLYTIC team is extremely competent, diligent and fun to work with. They solve problems and offer support wherever it is needed to get a project up and running. We have already set up multiple studies with RAYLYTIC and are also cooperating on several other projects.
DR. ANDREA WEILER
Director Medical Scientific Affairs at Aesculap/B. Braun
We have built databases for two retrospective studies including image analyses with RAYLYTIC. They helped with designing the eCRF, implemented and trained us on how to navigate the database, provided necessary documents and went above and beyond to help us achieve our goals. Working with RAYLYTIC is fantastic. The team is highly professional and extremely knowledgeable on how to run clinical retrospective studies.
DR. LAMIA BOSLI
Manager Clinical Data Management at RQMIS
RAYLYTIC has created a product that includes all the elements I need for my research, with the highest quality and integrity. In addition, the best part of this product is actually the customer service. I cannot stress enough how impeccable the entire team at RAYLYTIC is, which ultimately makes this product even better.
Senior Manager Clinical Studies at Virginia Spine Institute