MEDELIA (RealBit) eIFU module
RealBit S.r.l.
RealBit is a technology partner specializing in custom software development, offering solutions for digital transformation, particularly in the medical device sector with their eIFU module.
RealBit is a software house that acts as a technology partner for businesses undergoing digital transformation. They offer a range of IT services, including consulting, design, and custom software development tailored to specific client needs. Their expertise extends to providing "turnkey" solutions for the industrial and medical sectors. A key offering is the MEDELIA medical suite, which includes the eIFU module designed to manage electronic Instructions for Use (IFU) for Medical Devices (MD) and In Vitro Diagnostics (IVD). This solution simplifies IFU management, ensuring regulatory compliance and offering benefits like cost reduction, time efficiency, and sustainability. RealBit emphasizes a strategic approach to digitalization, understanding the complexities and potential hidden costs involved. They aim to provide comprehensive software solutions that not only address immediate needs but also prevent future complications, ensuring a strong return on investment and maintaining a competitive advantage for their clients.
About
**Who they are**
MEDELIA (RealBit) eIFU module is a specialized software solution developed by RealBit, a technology partner focused on custom software development, particularly for the medical device sector. They offer solutions for digital transformation, with a core focus on managing electronic Instructions For Use (eIFU).
**Expertise & scope**
* Digitization and hosting of Instructions For Use (IFU) for Medical Devices (MD) and In Vitro Diagnostics (IVD).
* Simplifying and accelerating IFU management through their eIFU module.
* Publishing eIFUs with included revisions, offering immediate access to correct documentation.
* Multi-language document management for articles and batches.
* Providing both Cloud and On-Premise deployment options.
* Developing custom software solutions, including their MEDELIA medical device software suite for post-market management, SINERGYA for production planning, and DataBridge for data synchronization.
**Reputation / proof points**
* Since 2021, RealBit has been a member of BioPmed, an innovation and research hub for the medical sector in the Piedmont region.
MEDELIA (RealBit) eIFU module is a specialized software solution developed by RealBit, a technology partner focused on custom software development, particularly for the medical device sector. They offer solutions for digital transformation, with a core focus on managing electronic Instructions For Use (eIFU).
**Expertise & scope**
* Digitization and hosting of Instructions For Use (IFU) for Medical Devices (MD) and In Vitro Diagnostics (IVD).
* Simplifying and accelerating IFU management through their eIFU module.
* Publishing eIFUs with included revisions, offering immediate access to correct documentation.
* Multi-language document management for articles and batches.
* Providing both Cloud and On-Premise deployment options.
* Developing custom software solutions, including their MEDELIA medical device software suite for post-market management, SINERGYA for production planning, and DataBridge for data synchronization.
**Reputation / proof points**
* Since 2021, RealBit has been a member of BioPmed, an innovation and research hub for the medical sector in the Piedmont region.
Additional information
The eIFU module is designed to streamline the process of managing Instructions For Use for medical device manufacturers. Key features include instant revision publishing, real-time notifications to healthcare professionals, and flexible search functionalities via a web portal. The solution aims to reduce risks, save time and money, and enhance customer experience by providing immediate access to the correct eIFU. RealBit emphasizes the importance of understanding regulatory requirements, such as those from MDR and EUDAMED, when transitioning to eIFU to avoid compliance issues and operational complications.
Key Highlights
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Offers a specialized eIFU module for managing Instructions For Use for Medical Devices and IVDs.
Source
“Digitize and host your IFUs on our modular software platform MEDELIA.”
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Provides multi-language document management for articles and batches within the eIFU module.
Source
“Multi-language document management, articles and batches”
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RealBit is a member of BioPmed, a leading innovation and research hub for the medical sector.
Source
“Since 2021, RealBit is a member of BioPmed, the leading innovation and research hub for the medical sector in the Piedmont region.”
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The eIFU solution is available in both Cloud and On-Premise versions.
Source
“Available in Cloud and On-Premise versions”
Certifications & Trust Signals
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RealBit has been a member of BioPmed since 2021.
Source
“Since 2021, RealBit is a member of BioPmed, the leading innovation and research hub for the medical sector in the Piedmont region.”
Buyer Snapshot
Best for
- Medical device manufacturers (MD and IVD) seeking to digitize IFUs.
- Companies looking to improve compliance and reduce costs associated with IFU management.
How engagement typically works
- Project-based custom software development.
- Solution provider for digital transformation in the medical sector.
Typical deliverables
- eIFU module software (Cloud or On-Premise).
- MEDELIA medical device software suite.
- Custom software development services.
Good to know
- Best when a specialized solution for eIFU management is required.
- Requires understanding of regulatory landscape for medical devices.
HQ:
Vercelli, IT
Languages:
English, German, French, Italian
Timezones:
UTC+1
Status:
listed
Services & Capabilities
eIFU & Implant Card Platform
Pricing model:
Custom pricing
Hosting Model:
Hybrid
Paper On Request Fulfillment:
Not supported
Multilingual Support:
Yes
Qr Or UDI Linking:
Yes
Validation Pack:
No
Implant Card Support:
Indirect (QR/URL)
Compliance Certifications:
MDR, EUDAMED
Additional eifu_platform Details
Hosting Details
Offers both Cloud and On-Premise deployment options for the eIFU module.
Compliance Certifications
Focuses on compliance with EU regulations for medical devices (MDR) and IVDs regarding electronic Instructions For Use.
