MeDeLiA – the complete and modular solution for Medical Devices and In Vitro Diagnostics manufacturers, compliant with MDR
Choose the full suite or the specific modules you need, among PMS (Post-Market Surveillance), PMCF (Post-Market Clinical Follow-up), and eIFU (Electronic Instructions for Use).
RealBit supports manufacturers of medical devices and in vitro diagnostics with innovative software solutions. We are proud members of BioPmed, the leading innovation cluster dedicated to Health and Life Sciences in the Piedmont Region.
Discover MeDeLiA and its modules!
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A modular solution that grows with your needs
MeDeLiA is the ever-evolving software suite designed to meet the needs of medical devices and in vitro diagnostics manufacturers.
Thanks to its modular design, it provides a solution that aligns with your current needs and can grow with you to address new requirements in the future. Every module of MeDeLiA is fully integrable with the other modules in the suite.
MEDELIA MODULES
Safety, Compliance, and Efficiency
With an intuitive interface and streamlined processes, MeDeLiA optimizes post-market surveillance and clinical follow-up operations, enhancing productivity and reducing response times.
Post-Market
Surveillance
Analyze market feedback and improve the quality of your devices.
Post-Market
Clinical Follow-up
Collect clinical data, monitor risks, and track the performance of your devices.
electronic Instruction For Use
The simplified and cost-effective solution for managing digital instructions for use (IFU).
WE ARE YOUR IDEAL PARTNER
RealBit offers a complete and modular solution for manufacturers of medical devices and in vitro diagnostics.
Starting January 2025, Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) will become essential tools for medical device manufacturers to maintain compliance during certification. Originally launched as eIFU, our solution for managing electronic instructions for use has grown into a comprehensive medical suite designed to meet the diverse needs of medical device and in vitro diagnostic manufacturers.
Discover the benefits of navigating digital transformation and adapting to new regulations with a single, trusted technology partner.
Available in Cloud or On-Premise
Choose MeDeLiA in the cloud, hosted on RealBit servers compliant with medical industry regulations such as high-availability systems, redundancy, and constant backups.
Install MeDeLiA on your company’s servers, download the brochure to learn more about hardware requirements.
MeDeLiA and Regulations
A regulatory landscape in constant evolution
Every MeDeLiA module complies with European regulations. RealBit provides each software module with the validation documents required by current standards (FDA and MDR), ensuring that the software is ready to pass your certification process.
In this section, you will find the regulations and guidelines that MeDeLiA modules adhere to.
Regulations and Guidelines
The EU Regulation 2017/745 of April 5, 2017, regarding medical devices, establishes the requirements for post-market surveillance (PMS) and post-market clinical follow-up (PMCF) to ensure the continued safety and performance of medical devices. It includes detailed provisions on PMS and PMCF plans.
• Articles 83-86: Specify manufacturers’ obligations concerning PMS.
• Annex XIV, Part B: Details the requirements for PMCF.
Similar to the MDR, the IVDR requires manufacturers of in vitro diagnostic devices to implement post-market surveillance (PMS) and post-market clinical follow-up (PMCF) plans.
• Articles 78-81: Specify manufacturers’ obligations concerning PMS.
• Annex XIII, Part B: Details the requirements for PMCF.
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Don’t hesitate to contact us! We’ll be by your side every step of the way, providing full support throughout the implementation process. Learn more about the platform by downloading the brochure or request a demo video to see it in action!