& Life Sciences
Elevate Medical Device Software Development for Enhanced Patient Care
Have a vision for a new medtech product? Need help updating an existing product? ICS leverages deep domain expertise, specialized tools, ISO 13485-compliant processes, and a suite of services to streamline development, testing and certification of medical devices, in vitro diagnostics, scientific software and SaMD.
Applying IEC 62366, our software developers, HFE specialists, UX designers, cybersecurity pros, QA and test specialists, and regulatory experts create robust, compliant products suitable for 510(k) submission. And we do it while reducing development costs, enhancing software performance and compressing timelines in the process.
Simplify Your Journey to Compliant Products
Our consulting services span every phase of product development from software strategy and design through post-market support.
Experts in embedded and desktop systems development, ICS’ expansive in-house team of software engineers works with you to create superior-quality medical devices and scientific applications. With hundreds of successful products to our credit – from clinical devices to in vitro diagnostics – we have the experience to help you create high-performing products that foster improved patient outcomes.
As your end-to-end software development partner, we offer the targeted services needed to turn your vision into an exceptional product:
- Full-stack custom software development
- GUI development and prototyping
- Application and web/cloud development
- Low-code tools that accelerate transition from prototype to product
In tandem with our UX design firm Boston UX, ICS helps create transformative products for medical and life science markets. We apply design thinking best practices to understand the problem within the context of your product roadmap and regulatory landscape, and design highly usable devices and applications that advance patient care.
To support our strategic, human-centered approach — built on data-driven insights — we offer an array of UX design services that span your project's life cycle:
- UX strategy
- IEC 62366 design
- Information architecture & functional flows
- Wireframing and prototyping
- Visual & motion design
- User testing & usability
- HFE research & design
- Formative testing (UX)
Our medtech regulatory specialists provide strategic services throughout the life cycle of your medical device or in vitro diagnostic device. Our goals are to help you avoid development obstacles and streamline compliance efforts as you work toward market introduction.
Compliance can be challenging in light of ever-evolving regulations. ICS offers the focused services you need to ensure that your regulated medtech product is safe and effective for its intended use:
- 3-week regulatory review
- 13485 compliance (Quality System)
- 62304 compliance (SDLC)
- 62366 compliance (Usability Standard)
- 14971 compliance (Risk Management)
- Corrective & preventive actions (CAPA) management
- Compliance remediation
- Secure configuration management
- Design History File (DHF) documentation
- Planning worksheet
- Requirements management
- Quality Management System (QMS)
Every software application needs to undergo stringent testing before being released to users. ICS offers a spectrum of system, integration, automation and regulatory testing services to help you improve product quality and user satisfaction, enhance device cybersecurity, spot preventable errors, and mitigate costs by identifying defects early when they are less expensive to fix.
Say goodbye to bugs! With ICS' product testing services, you'll benefit from the speed and accuracy of automation testing via tools like Squish, and the deeper insight and flexibility of our manual testing methodologies.
- Test planning
- Requirements analysis
- Verification planning
- Verification testing
- UX formative testing
- Engineering testing:
- Unit tests
- Integration tests
- Code reviews
- Static and dynamic analysis
- Ad hoc testing using simulators
- System testing
If you require testing services beyond the scope of our practice, for instance summative, validation or penetration testing, we can introduce you to one of our trusted partners that specializes in these areas.
We offer secure, maintainable and scalable cloud-native solutions to help you design, develop and deploy your product in a way that complies with regulatory requirements, such as developing under design controls (ISO 13485 and IEC 62304) and adhering to HIPAA privacy rules regarding PHI.
To help you manage the complexities of regulated medical markets we offer a range of targeted IoT (and IoMT) services, including:
- Cloud-native development leveraging AWS, Azure and purpose-built medical cloud providers
- IoT solution design, development & analytics
- Cloud architecture & engineering
- IoT device fleet management
Federal regulation applied in March 2023 as part of the PATCH Act (Protecting and Transforming Cyber Health Care) mandates heightened levels of cybersecurity compliance for new medical devices in order to keep up with rapidly evolving cyber-threats resulting in ransomware attacks and stolen consumer data.
The FDA's guidance applies to medical devices that contain software or that are designed to be connected to the internet — even if they're never connected. It also extends to previously authorized cyber devices for which the manufacturer is now making a change to the device that requires premarket review by the agency.
ICS provides critical services to help you safeguard your medical device and streamline compliance:
- 510(k) submission documentation
- Gap analysis for FDA's April 2022 guidance
- Threat modeling assessment
- Monitoring & annual cybersecurity report
- Software Bill of Materials (SBOM) generation
- Submission or pre-submission documentation
- Secure Product Development Framework (SPDF) compliance
- Manufacturer's Disclosure Statement for Medical Device Security (MDS)
- Static analysis compliance & report
- UL 2900 assessment
"We partnered with ICS for the software development of our CellFX® System, our first commercial product, which has received 510(k) clearance by the FDA and CE mark approval both earlier this year. As with all medical devices, design considerations are paramount to ensure functionality, safety and usability. That’s where ICS’ expertise was essential in helping us build an intuitive software-enabled, cloud-engaged device that offers discerning aesthetic skin specialists exceptional and seamless ease of use."
ICS helped a medtech innovator develop a revolutionary ex vivo lung perfusion system to keep donated lungs healthy during transport.
ICS helped Ivenix combine next-gen technology with simplicity in its FDA-approved intelligent fluid delivery system.
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Blogs and Resources
Skipping or scrimping on medical device software testing is not an option. Read more in our article in Medical Design & Outsourcing.
The FDA now mandates elevated levels of cybersecurity compliance. Streamline the process with our handy cybersecurity documentation checklist.
By partnering with ICS, you’ll benefit from accelerated time to market, decreased development inefficiencies, diminished development risk, and cost savings from enhanced usability.