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Medical Device Software
We develop software for medical devices in compliance with the IEC 62304 standard, ensuring a structured, traceable, and quality-driven development lifecycle. Our process covers requirements definition, architecture design, implementation, verification, and validation, with full documentation and risk management integrated at every stage. We follow best practices for software safety classification, change control, and version management to meet regulatory expectations and support certification.
With experience across multiple medical device projects, we apply an Agile development process in a way that stays compliant with IEC 62304 under a QMS based on either ISO 13485 or ISO 9001.
By aligning development activities with IEC 62304, we help clients build reliable, high-quality medical device software that meets stringent safety, performance, and regulatory requirements.
Tell us what you're building — a prototype, an automated test system, or software for a regulated device — and we'll tell you honestly whether we're the right fit.
