Develop safety‑critical firmware and software that controls medical devices and meets FDA and IEC 62304 expectations for reliability, validation, and traceability.
ISO 13485:2016 certification defines how medical device and software development must be planned, controlled, and documented to meet regulatory expectations.
At CLEIO, this certification is applied through a structured quality management system that guides design controls, risk management, verification, and validation across every development phase. Our Quality Assurance team works directly within each project to apply requirements and produce the technical documentation needed to support FDA and international regulatory compliance.
Quality Management System
Risk Management
Software Lifecycle for Medical Device
Electrical Safety for Medical Electrical Equipment
Usability Engineering for Medical Device
We have collaborated with Soundbite Medical to design and develop the latest commercial version of their medical device.
4.6 / 5 Stars Customer Satisfaction Rating
Working with CLEIO has been an outstanding experience. Their seamless integration with our internal resources has greatly enhanced our approach to product design, always prioritizing the patient and their unique needs. The team's exceptional communication, effective project management, and technical expertise across the board have made every collaboration smooth and impactful. CLEIO's ability to bring innovative solutions while maintaining efficiency has truly set them apart, making them an invaluable partner in our efforts to create meaningful, patient-centric designs.
With the support of CLEIO, we are more confident than ever in the decisions made. All members of the CLEIO team are great experts and professionals, covering a broad spectrum of aspects that a medical device project needs. They approach their work with pleasure, dedication, and motivation.
To undertake ambitious large-scale projects, choosing the right partners is essential. The CLEIO team leverages its expertise and ingenuity, and mobilizes passion and ressources as a partner in developing our groundbreaking cancer treatment technology.
In addition to their expertise, CLEIO provided us with excellent communication throughout the entire process. They also made the most of every minute of our strict timeline. Working with CLEIO has ensured a solid foundation for future product development.
Working with CLEIO allowed us to quickly show investors a certified, effective, well-designed, and attractive ready-to-market medical device that addresses critical human factors in a hospital environment. We’re moving forward with additional certification and collaborating with our CLEIO team on the next phase of development.
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