Developing and upgrading software for In Vitro Diagnostic (IVD) medical devices presents both exciting opportunities and significant challenges. Whether upgrading existing Research Use Only (RUO) software to meet IVD regulatory requirements or developing new software for diagnostic purposes from scratch, careful planning and strict adherence to regulatory standards are essential.
Given the frequent questions we receive on the topic of IVD software development, we’ve compiled a detailed Q&A to guide you through the process.
Can existing RUO software be upgraded to IVD?
Absolutely. Upgrading RUO (Research Use Only) software to IVD (In Vitro Diagnostic) software is possible, but a comprehensive gap analysis is required to identify missing features and documentation required by IVDR.
Fortunately, the software development process doesn’t need to start from scratch. By building on your existing software, you can integrate functionalities like audit trails, user management, and other compliance-related features required for IVD. Additionally, you’ll need to ensure all documentation, risk management files, and software validation meets the necessary regulatory standards.
You can read more about transitioning from RUO to IVD in our blog article The Difference Between IVD and RUO Software.
Does it make sense to develop both RUO and IVD software versions?
Yes, developing both RUO and IVD versions of the software makes sense. Here’s why:
- Your product can address the needs of both research and diagnostic markets and
- The research version can be used to test, validate, and improve the product before you design the IVD version.
Let’s dive into more details. Research software tends to offer greater flexibility in how users interact with it. This could include workflow configuration, parameter settings, data interpretation, and data visualization.
On the other hand, diagnostic software follows pre-defined standardized workflows and procedures, where flexibility should be restricted as much as possible. Diagnostic workflows need to ensure fast throughput and reliable results that are not affected by subjective interpretation.
Moreover, before your product can be marketed as an in vitro diagnostics, it needs to be certified, which is both a costly and time-consuming process. Therefore, it’s important to release a stable, reliable product that doesn’t require major revisions after launch. That is why most companies develop a research version first to validate and optimize the product. This process—both internal and external validation—is key to gaining valuable insights into product performance and usability. Once the performance is reliable and usability is clear, the IVD version can be developed to meet the specific demands of the diagnostic market.
How long does it typically take to develop IVD software?
The timeline for IVD software development depends on the complexity of the project, but it generally ranges from nine months to several years. This period covers all phases, including planning, documentation, prototyping, testing, and deployment. Complex projects with more demanding regulatory requirements or custom features may take longer.
How long does it take to develop IVD software compared to non-IVD software?
IVD software development usually takes longer than non-IVD software due to the additional regulatory requirements. IVD software must be developed in accordance with IEC 62304 and has to include functionalities like audit trails and user management (as per FDA 21 CFR Part 11).
The entire development process needs to be thoroughly documented, which can extend the project timeline by approximately 10% to 30%, depending on the complexity of the software. These regulatory requirements add significant time—often measured in months—compared to non-regulated software projects.
How long does it take to upgrade RUO software to comply with IVDR?
Upgrading RUO software to comply with IVDR can take anywhere from six months to 1.5 years, depending on the complexity of the software system and the extent of the required updates. Conducting a gap analysis is a crucial first step in estimating the upgrade’s timeline and budget.
If we already have existing software, do we need to develop and prepare everything from scratch, including documentation?
No, you don’t need to start from scratch. Building on your existing software and documentation is entirely possible. However, a gap analysis will help identify any missing elements that need to be addressed to ensure regulatory compliance and your target market.
After identifying these gaps, you can incorporate the necessary compliance elements.
You can learn more about how to increase efficiency in IVD software development in our webinar, where our experts take you through the process of best practices in IVD software development.
Does upgrading existing RUO software typically save time and resources compared to starting from scratch?
Yes. Upgrading existing RUO software can save time and resources compared to developing new software from scratch, which can give you a competitive advantage over the competition.
A gap analysis can identify the necessary updates or additions, and the existing software can often be adapted to meet IVD regulatory requirements. This approach is usually more cost-effective and time-efficient, particularly if the existing software already has some regulatory features in place.
What software documentation is required for an IVD software technical file?
Documentation is vital for IVD medical device software to ensure compliance with regulatory standards such as IEC 62304. It provides a detailed record of the entire development process and ensures that the software is developed and maintained in a safe, compliant manner, with each requirement tested thoroughly.
Here is a breakdown of the key documents required at six steps of the software life cycle. For a more comprehensive list, you are invited to watch our webinar:
- Planning: Software Development Plan
- Requirements Analysis: Software Requirements Specification (SRS), Software Design Specification (SDS), and Software Verification and Validation Plan
- Architectural Design and Detailed Design: Software Architectural Design, Log of SOUP (Software of Unknown Provenance), Integration Test Plan (optional), software Detailed Design, and Software Configuration Management Plan
- Implementation: Unit Test Plan, Unit Test Report, Integration Test Report (optional), and version Description Document:
- Verification: System Test Report
- Deployment: Version Description Document
For a deeper dive into the documentation requirements in every step of the software development lifecycle, check out our whitepaper on IVD medical device software development and regulations or watch our webinar How to approach IVD software development.
What are the cost differences between IVD software development and non-IVD software?
The costs of developing IVD software are typically higher due to the extensive regulatory requirements and documentation. The number heavily depends on the project size and complexity.
However, there are several ways to reduce costs, such as using ready-made software modules for critical standardized features, like audit trail and user management. If you have a broader software portfolio, it makes sense to develop libraries in-house.
You can also contact software development companies that specialize in IVD software development. They might be able to help with pre-ready software modules that include all the necessary documentation, helping streamline the process of software development.
A lot of time and money can be saved on software documentation using pre-ready templates and/or dedicated software. There are several currently on the market, such as Confluence and Greenlight Guru.
Are you planning your next IVD or RUO software project?
Our team of software developers is here to guide you every step of the way, ensuring compliance, efficiency, and success. Contact us to discuss your project and see how we can help accelerate your process of software development.
