Hardware-Software Medical Device Development

Accelerate Hardware-Software Integration with AI-Native Compliance

Unified Compliance for Hardware-Software Medical Devices

For medical device teams building hardware, firmware, and software components, fragmented tools and manual workflows are the biggest barriers to fast releases. Ketryx unifies mechanical, electrical, and software development in a single AI-native traceability platform, enabling faster hardware-software integration while maintaining compliance with the FDA, ISO 13485, IEC 62304, and IEC 60601.

To build hardware-software medical devices, teams must coordinate across disciplines without sacrificing velocity.

Complex medical devices require careful coordination between mechanical design, electrical engineering, firmware, and software teams. Traditional compliance approaches create silos between disciplines and force manual handoffs that slow releases. How do you maintain traceability across hardware, firmware, and software without stopping engineering teams for documentation exercises?

One AI-Native Platform for Hardware, Firmware, and Software

Ketryx provides an AI-native platform for hardware-software medical device development. Manage requirements, specifications, and design documentation across all disciplines while AI maintains end-to-end traceability, identifies gaps, and accelerates critical tasks from system requirements through implementation and verification.

"Ketryx has allowed us to channel our hardware and software engineers' existing set of development, testing, and documentation practices directly into the generation of compliant documentation with minimal additional burden. This has allowed us to remain agile while delivering high-quality products."

Alexander Chan VP of Analytics and Machine Learning

Manage Hardware and Software Requirements in One System

Define system-level requirements and decompose them into hardware specifications and software requirements. Maintain bidirectional traceability as requirements evolve throughout the product development lifecycle.

Eliminate manual copying of requirements between hardware and software tools

Track requirement changes across mechanical, electrical, and software domains automatically

Maintain compliance with ISO 13485, IEC 62304, and FDA design control requirements

Draft new requirements from design documents and identify redundancies across hardware and software domains with Ketryx AI

Model complex hardware-software systems as interconnected subsystems

Define your product architecture with mechanical assemblies, electronics, firmware, and software as traceable subsystems. This supports independent release cycles for software when hardware hasn't changed.

Model multifunction devices with medical and non-medical components

Ship software updates without re-validating unchanged hardware components

Support system of systems architectures for device families and platforms

Analyze architecture changes and identifies cross-domain impacts across mechanical, electrical, and software subsystems with Ketryx AI

Connect code repositories and requirements tools in real-time

Integrate GitHub, GitLab, Jira, Polarion, and JAMA to maintain traceability as teams build. Developers and hardware engineers stay in their preferred tools while traceability updates automatically.

Trace tests and verification activities across hardware and software

Automatically link hardware test protocols, software automated tests, and firmware validation activities back to requirements and risks, and generate verification documentation continuously.

Manage Complete Product Lifecycle Across Hardware and Software

Support the complete product lifecycle with change control, cybersecurity management, component obsolescence tracking, and post-market surveillance across hardware-software product families.

AI Agents

Accelerate critical tasks with safety-critical AI that keeps humans in the loop.

"Ketryx AI is the most scalable approach we've used for regulated product development. It lets our teams make frequent, safe changes while staying continuously audit-ready, without relying on linear headcount growth or stopping teams for compliance exercises."

Lucas Fernandez Director of Medical Devices

Change Impact Assessment

When hardware changes affect software, or vice versa, Ketryx AI analyzes cross-domain dependencies automatically.

Reduce change planning from weeks to days across mechanical, electrical, and software domains

AI reasons through how hardware changes affect firmware and software requirements

Auto-generate updated requirements, risks, and test procedures

Requirements Intelligence

AI drafts new requirements, checks for redundancies, and identifies test coverage gaps.

Risk Generation

AI identifies hazards from DHF, QMS, and external databases like MAUDE, then drafts risk assessments when requirements change.

Test Case Generation

AI drafts verification test cases and identifies coverage gaps across hardware and software requirements.