Custom Software Development Services
Gener8 specializes in custom software development for all types of products, including those in heavily regulated markets.
We offer comprehensive software development services for FDA-regulated medical devices, Research Use Only (RUO) solutions, and a wide range of applications across industries. From stand-alone software to embedded systems in complex instrumentation, we help medical, biotech, life sciences, and other companies—from startups to global enterprises—tackle their most challenging technical needs.
Gener8 Solves Software Challenges
Developing software for regulated industries comes with unique challenges, from compliance hurdles to cybersecurity risks.
Gener8 provides expert solutions to ensure your project stays on track and meets all necessary requirements.
Key Challenges We Solve:
✅ Ensuring robust cybersecurity measures
✅ Managing complex test strategies (unit, integration, system testing, security)
✅ Seamless hardware integration
✅ Enhancing usability and user experience
✅ Ensuring software scalability and performance
✅ Balancing speed and quality in development cycles
✅ Compliance with stringent regulatory and quality standards (IEC 62304, ISO 14971) when necessary
✅ Generating comprehensive documentation for regulatory submissions (DHF) when necessary
The Cost of Software Challenges:
Without the right expertise, software development obstacles can lead to significant setbacks, including:
⚠️ Delays in Time to Market – Slowed development cycles impact launch timelines
⚠️ Regulatory Failures – 64% of 510(k) submissions fail on the first attempt
⚠️ Customer Dissatisfaction – Low-quality software affects user trust and reliability
⚠️ Rising Project Costs – Inefficiencies and rework drive up expenses
⚠️ Overhead from Large Teams – Maintaining in-house development teams becomes costly
Your Project Deserves a Specialist
50+ Full Time Engineers
65% Software Engineers
35% Verification Engineers
15+ Average Years
of Experience
100+ Approved Medical Devices
FDA Class I, II and III Devices
SaMD
Research Use Only
Specialized Software Services
At Gener8, we provide tailored software solutions designed for the unique needs of medical devices, life sciences, and biotech industries.
Whether you’re developing a standalone digital health application or embedded software for laboratory instruments, our expertise ensures a seamless
path from concept to regulatory approval.
Instrument Software
SaMD
(Software as a Medical Device)
Cybersecurity
Cloud Solutions
Verification and Validation
QMS
(Quality Management System)
Proven Approach
Proven Methodology
Proven Performance
Ready-to-Use Software Products
We offer high-quality medical device software products, successfully integrated into numerous FDA-approved devices.
Built with customer input, our solutions come with full documentation, test suites, and flexible licensing options (binary or source code) to fit your needs.
Whether you need to jump-start development, connect to LIS systems, or manage field instruments, we have a product designed for you.
Application Accelerator
A proven software architecture and framework of services leveraged to jump-start the development of custom software solutions.
Accelerate custom software development with a pre-built, regulatory-compliant framework, saving up to six months of development time.
- Modern, customizable UI
- Built-in reporting, logging, and auditing
- Cross-platform support
(Windows & Linux)
- Extensive unit tests and
continuous updates
LIS & EHR System Connector
Providing immediate connectivity between medical device software products and LIS and EHR systems.
Seamlessly connect medical device software with LIS and EHR systems, reducing integration time and ensuring regulatory compliance.
- Immediate LIS/EHR connectivity
- Simplified integration process
- Reduces development and verification timelines
Device Management Portal
Providing a secure, easy-to-use solution for managing a fleet of instruments.
Secure, cloud-hosted platform for managing instrument fleets with real-time insights and remote capabilities.
- Remote updates and troubleshooting
- System usage tracking
- Comprehensive reporting tools
Why Choose Gener8 for Software Development?
Developing high-quality, compliant software is complex—Gener8 makes it seamless.
Our expertise ensures your project meets regulatory requirements, avoids costly delays, and delivers exceptional performance.
What Sets Us Apart?
✅ Cutting-Edge Software Development – We stay ahead with the latest technologies
✅ Regulatory Expertise – Deep knowledge of industry standards and evolving requirements
✅ Cost & Time Efficiency – Reduce unnecessary expenses and accelerate time-to-market
✅ Biomedical Algorithm Integration – Transform complex algorithms into testable, functional code
✅ Comprehensive Verification & Validation – Ensure your software is ready for approval
✅ Proven Track Record – 25+ years of experience in medical software development
Regulatory Compliance & Expertise
Navigating regulatory requirements can be overwhelming.
Gener8 ensures your software is built to meet the highest standards, including:
📌 FDA 21 CFR Part 820 – Quality system regulations
📌 ISO 13485 – Quality management for medical devices
📌 IEC 62304 – Software lifecycle documentation
📌 ISO 14971 – Risk management compliance
📌 CLIA Waived Devices – Regulatory pathway support
📌 Class I, II, & III Medical Devices – Expertise across all classifications
📌 Cybersecurity – Ensuring software integrity and data protection
📌 Comprehensive Verification – Thorough testing for regulatory approval
Browse Software Case Studies
Thousands of projects completed.
We’re proud to serve the Biotech, Medical, and Industrial markets.