Reduce the challenges of medical registry management
Designing a medical registry requires careful and calculated effort that can strip departments of time, money, and other resources.
A well-built medical registry requires:
- Long-term patient contact
- Regulatory & patient data protection
- Accurate data input, transfer, and processing
- ePROs & product data
- Adaptability throughout device's lifetime
- Structured, analyzable data
Medical registry optimization with UNITY
We provide an intuitive platform for managing your medical registry: efficient, customizable and interoperably applicable.
Data Protection
Patient Notification
AI-Supported Analysis of Imaging Data
Integration of ePROs
Data Capture for EU-MDR Post-Market Surveillance
Interoperability
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.
Maintaining a medical registry represents 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.
Are you getting the most value out of your clinical data?
Make sure the must-have technical features of a registry software with our free checklist.
Integrate electronic patient-reported outcomes (ePROs) into your medical registry
ePROs capture the long-term efficacy of treatments from the patient’s point of view when included in a medical registry.
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 the UNITY platform.
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.
The UNITY platform assists stakeholders in aggregating patient-reported outcomes and radiographic images over time for maintaining a comprehensive medical registry 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.
- Alleviate medical personel of administrative tasks
- Fulfill regulatory & patient data protection requirements
- Optimize long-term data collection for EU-MDR
- Automate manual procedures
How RAYLYTIC customers profit from our solutions:
As we bring forward more accurate tools for implant placement, we are in need of better methods to assess postoperative alignment and accuracy to planned placement. It seems you have not only filled that need, but also automated the process of acquiring accurate information.
RUSSELL SCHENCK
Director Clinical Strategy at Zimmer Biomet
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.
LINDSAY OROSZ
Senior Manager Clinical Studies at Virginia Spine Institute
The sites and CROs involved in the trials are so relieved to finally have a platform that automates redundant tasks and ensures highest quality data with little extra effort. Our CROs and principal investigators have been extremely impressed with the quality of data coming out of sites and their interactions with RAYLYTIC.
ANDY MURILLO
Spinal Stabilization Technologies
With the use of UNITY, the basis was laid for not having to maintain or introduce an unlimited number of individual solutions for the processing of PROMs and PREMs. This relieves IT managers in the long term.
DANIEL WUNDERLI
ICT-Project Manager at KSW
With UNITY, we are offering surgeons an intuitive way to generate and access meaningful registry data.
DAVID OKA
VP Business Development and Compliance at Innovasis