“Our benefit comes in not just understanding the software development piece, but understanding all the other pieces that need to be considered. We know what the FDA cares about so we can help you focus your time on the things that truly matter for clearance or approval.”
–Chad Gibson, Managing Partner
CMD MedTech provides comprehensive software development services for medical devices, helping companies navigate IEC 62304, AAMI TIR45, FDA guidance, and other regulatory requirements. Our team offers technical leadership through the entire software development lifecycle, ensuring compliance with US (FDA) and international requirements while maintaining efficient development processes so you can get your device to market faster.
Why Choose CMD MedTech for Medical Device Software Development
- Expertise in medical device software standards, regulations, and guidance while understanding the entire development context
- Strategic coordination of software development with hardware timelines and regulatory requirements
- Experience balancing compliance with efficient development, focusing on the right level of documentation
- Ability to integrate Agile software development practices in accordance with AAMI TIR45 and FDA guidance
- Ability to translate between software teams, regulatory expectations, and quality requirements
- Deep working knowledge of FDA’s latest priorities for software, including cybersecurity and risk management
- Expertise in properly documenting software architecture, design, and testing for successful submissions
Benefits of CMD’s Software Development Expertise
- Avoid costly rework or refactoring by implementing the right processes from the beginning
- Meet project deadlines with efficient, well-planned development timelines that consider software’s role in other workstreams
- Reduce development costs by focusing on the right level of documentation and testing
- Accelerate time-to-market through strategic planning and coordination with hardware teams
- Minimize business risk by ensuring compliance while giving your developers the flexibility they need
PRICING FOR OUR SOFTWARE DEVELOPMENT SOLUTIONS
Our software development services are customized based on your specific device, software complexity, and risk classification. We offer flexible engagement models to match your needs, whether you require complete development oversight or support for specific aspects of the process. Contact us to discuss your project requirements and how we can help.
5-Step Process for Getting Started With Our Software Development Services
Software Development Standards and Compliance
Additional Services We Provide
Comprehensive Cybersecurity
We incorporate medical device cybersecurity requirements throughout the development process and help protect your device from vulnerabilities.
AI and Machine Learning Support
Our team provides guidance on implementing AI and machine learning technologies in medical devices and navigating the complex regulatory considerations, including recent FDA guidance.
Quality System Integration
We develop software development procedures that integrate seamlessly with your existing quality management system.
Software Lifecycle Management
Our team implements systematic processes for tracking bugs during development and post-market, including updates and issue resolution.
FREQUENTLY ASKED QUESTIONS ABOUT SOFTWARE DEVELOPMENT FOR MEDICAL DEVICES
Medical device software development requires a more rigorous approach with comprehensive documentation and risk management. The FDA treats software differently than hardware, (e.g., assuming that if software can fail, it will fail). This requires redundancy, isolation of mission-critical systems, detailed risk controls, and thorough testing at multiple levels to ensure patient safety.
Yes, we can lead your team through the medical device software development process, helping them understand regulatory requirements without hindering their productivity. We create a balance that allows developers to work efficiently while ensuring compliance with necessary standards, providing guidance on timing and approach rather than replacing your development resources. We are able to adapt your existing Agile or other iterative design processes to work with the regulatory requirements of medical device software development.
AI and machine learning add complexity to medical device software regulation. The regulatory pathway varies significantly depending on how AI is used in your product. We help determine the appropriate approach based on your specific implementation, guide development to meet FDA expectations, and prepare documentation that addresses FDA’s concerns about AI-based medical products. Our team stays up-to-date with FDA’s evolving stance on AI in medical devices.
While software development and cybersecurity are separate work streams, they’re tightly integrated in medical devices. We ensure cybersecurity considerations are addressed throughout the development process, from early architecture decisions to final verification. Our approach follows the FDA’s expectations for cybersecurity, incorporating threat modeling, vulnerability assessments, and appropriate risk controls.
We can evaluate your current development state, identify gaps against regulatory requirements, and create a remediation plan. While it’s ideal to implement compliant processes from the beginning, we can help transition existing software into a compliant framework with minimal rework, focusing on essential elements needed for patient safety and regulatory acceptance.