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In Vitro Diagnostics Software Development Services
With 19 years in healthcare software development, ScienceSoft provides full-cycle IVD software services, from design and development to assistance in regulatory submission.
In vitro diagnostics software development focuses on creating innovative and convenient solutions for lab or at-home health monitoring. Having hands-on experience delivering specialized IVD software, ScienceSoft develops IVD solutions following the requirements of FDA, IVDR, and ISO 13485.
IVD Solutions We Develop
For physicians
Clinical decision support systems, IVD interpretation and reporting software
For lab technicians
IVD quality control software, IVD analytics software
For patients
Software for at-home diagnostic and monitoring devices
ScienceSoft as an IVD Software Product Development Partner
- In healthcare IT since 2005.
- 150+ projects for the healthcare industry, including IVD software and Software as a Medical Device (SaMD) projects.
- 750+ specialists, including certified IT consultants, engineers, and project managers with 5–20 years of healthcare IT experience.
- Over 50% of our IT talents are senior-level specialists.
- Experience with HL7, FHIR, XDS/XDS-I, and other healthcare data exchange standards.
- Regulatory consultants to ensure compliance with FDA, IVDR, HIPAA, GDPR, GCC regulations (MOHAP requirements, ADHICS, PDPL), and Australian Privacy Principles.
- Software documentation according to ISO 13485, ISO/IEC 82304-1, IEC 62304, GxP, 21 CFR Part 820.
- ISO 9001, ISO 27001, and ISO 27701 certifications.
What makes ScienceSoft different
We achieve project success no matter what
ScienceSoft does not pass mere project administration off as project management, which, unfortunately, often happens on the market. We practice real project management, achieving project success for our clients no matter what.
See Our IVD Software Development Expertise in Action
ScienceSoft’s Clients Say
bioAffinity Technologies hired ScienceSoft to help in the development of its automated data analysis software for detection of lung cancer using flow cytometry.
Our project required a large amount of industry specific methodology and algorithms to be implemented into our new software connected to EHR/LIS systems, which the team handled well. They are reliable, thorough, smart, available, extremely good communicators and very friendly.
During our cooperation, ScienceSoft proved to have vast expertise in the Healthcare and Life Science industries related to the development of desktop software connected to laboratory equipment, a mobile application, and a data analytics platform.
They bring top-quality talents and deep knowledge of IT technologies and approaches in accordance with ISO 13485 and IEC 62304 standards.
Working with ScienceSoft was a pleasure from A to Z. Their deep knowledge of the healthcare industry specifics and DICOM standard helped us create the back end of the software for our ultrasound scanner. We are grateful for their can-do attitude, responsiveness, and straightforward communication. RIVANNA already witnessed tangible benefits of our cooperation. We have more projects to come and are looking forward to working with ScienceSoft again.
ScienceSoft’s Services
With 19 years of experience in healthcare IT, ScienceSoft’s team is ready to drive state-of-the-art IVD technology, whether it requires new software development, legacy system modernization, regulatory submission, or support.
IVD software design
We will draw up the requirements, compose a secure architecture and tech stack, create a risk management plan, and design the UI/UX for your IVD software. ScienceSoft can also take over compliance and regulatory submission planning, following FDA, IVDR, and other applicable regulations.
IVD software development
ScienceSoft is ready to develop and test desktop, web, or mobile IVD software and integrate it with stationary and portable medical devices, custom and market-available EHRs, HIE, LIS, etc. We prioritize IVD software security and compliance and follow FDA, IVDR, and other local regulations and standards.
IVD software modernization and support
We can rearchitect or refactor IVD software, redesign UI/UX, improve cybersecurity, roll out new features, and create exhaustive documentation. We are also ready to provide long-term support and maintenance for IVD software.
IVD software documentation, submission assistance, and security assessment
ScienceSoft can create or review IVD software documentation, plan the submission according to FDA/IVDR requirements, and conduct security and compliance audits.
Frequently Asked Questions About IVD Software Compliance
What documents for IVD software submission to the FDA and IVDR entities do you provide?
From the very beginning of the project, ScienceSoft’s in-house regulatory consultants identify the applicable regulations and help plan the submission to the relevant authorities. Throughout the project, we create project documentation according to ISO 13485, ISO/IEC 82304-1, IEC 62304, GxP, 21 CFR Part 820, and other local requirements. The key documents we prepare are a Technical File (for the EU) and a Design History File, a Device Master Record, and a Device History Record (for the US). If you’d like to see a full list of IVD documentation we provide or have more questions about software compliance, drop us a line.
Do I need to resubmit the IVD software for clearance after modernization?
Yes, it’s a must. All changes to the key IVD software functionality may change the health risks it poses to the patients, so the software should be cleared by the relevant authority. If you’ve already upgraded the IVD software, ScienceSoft can review the documentation to detect and address insufficiencies and, if needed, create the missing files. If we modernize the IVD software, we create all the required documentation in parallel with the IVD product development.
What FDA registration pathway suits my project best?
The registration pathway for IVD software to be used in the United States is completely individual and varies from project to project. At the early software design stages, we define the submission strategy and identify the suitable registration pathway: FDA 501 (k), pre-market approval (PMA), or De Novo. Then, ScienceSoft’s team creates project documentation accordingly for smooth clearance and market launch.
How long does it take to get an IVD solution approved by a governmental authority?
In general, the regulatory review takes from 3–6 months. ScienceSoft applies its time-tested project, documentation, risk, security, and quality management approaches to steer clear of any avoidable delays in IVD software submission and clearance.
Key Steps to Develop IVD Software
1
Requirements engineering
At this stage, we thoroughly analyze your business needs, market, and competitors to help you plan the scope and requirements for the software. ScienceSoft’s in-house regulatory compliance consultants also verify that your IVD software falls under the Software as a Medical Device (SaMD) category, identify the class of the software, and define the FDA/IVDR submission strategy early on.
2
Technology solution design
During this step, we translate your IVD software requirements into feature lists, develop an architecture and integration plan, and pick a cost-efficient tech stack. Also, ScienceSoft’s team starts gathering the necessary system documentation to speed up the regulatory submission process later.
3
Development and testing
For innovative IVD products, we usually recommend starting with a proof of concept (PoC) to verify the technological and economic feasibility of the planned solution. Then, we proceed with developing and testing the in vitro diagnostics software according to ISO 13485, IEC 82304-1, and IEC 62304 best practices. The first functional version of IVD software is then submitted to the clinical trials on the customer’s side to validate its diagnostic efficiency.
4
Regulatory submission and launch
At this stage, the IVD software product should be submitted to the FDA or the notified bodies under IVDR for approval, according to the defined regulatory clearance strategy. If the authorities require IVD software changes to improve diagnostics safety, we implement the updates, and the software is resubmitted.
5
Post-launch support and evolution
ScienceSoft provides post-launch support and troubleshooting for 1–3 months as a part of the development agreement. Then, we can provide long-term L1, L2, and L3 support of the IVD software throughout convenient business hours: 24/7, 12/7, 12/5, 8/5. We can continuously maintain software security, manage software infrastructure, and help implement new IVD software features and integrations.
IVD Software Features in High Demand
Workflow automation
to simplify sample processing, data entry, and test interpretation while minimizing human errors and turnaround time.
IVD device monitoring
for quality and accuracy control, IVD device performance monitoring, and preventive maintenance.
Advanced IVD analytics
to enable trend identification, predictive health outcomes modeling, and spotting hidden dependencies between IVD results.
Integration capabilities
to connect IVD software to other healthcare IT systems (e.g., EHR) using ready-made APIs.
Interoperability
of IVD software for smooth data exchange between healthcare providers using HL7, FHIR, etc.
Mobile compatibility
and remote access for lab staff and patients using connected IVD devices.
Human-centered UX design
with user-friendly, responsive interfaces to speed up user adoption and simplify IVD workflows.
Data privacy
in line with HIPAA, GDPR, and other applicable regulations.
Technologies We Use to Develop IVD Software
IVD Software Costs
The pricing of IVD software highly depends on its purpose and functional scope. On average, the cost of developing custom IVD software starts from $200,000 to $400,000+.
Need a tailored quote for your project?
Other important cost factors include:
- IVD application platform (web, mobile, desktop).
- For mobile apps: the number of supported platforms (iOS, Android), the development strategy (cross-platform vs. native).
- The complexity of integration with the IVD devices and healthcare IT systems (e.g., EHR, LIS, lab results portal, physician portal).
- Number of user roles (e.g., patients, doctors, lab technicians).
- IVD software performance, data storage, and compliance requirements.
IVD Software Development Timelines at ScienceSoft
|
2 days – 2 weeks to discuss the project, make estimates, and kick off the development process. |
From 6 months to develop the first submission-ready version of IVD software. |
|
2–3 weeks for major software releases. |
1–8 hours for minor updates and fixes in the IVD software. |
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<30 minutes to respond to IVD software support tickets. |
1–4 weeks for a security and compliance assessment of IVD software. |