What tools reduce manual effort in medical device development?

Greenlight Guru streamlines product development by eliminating the need for spreadsheets and disconnected tools. Automated workflows, built-in templates, and centralized data help teams work faster and with fewer errors, so they can focus on building safer, more effective devices.

Can I build and manage multi-level BOMs while tracking design history automatically?

Yes. Greenlight Guru allows you to organize complex product structures with multi-level bills of materials while your design history file is updated automatically in the background, ensuring nothing gets missed as your device evolves.

Does Greenlight Guru provide end‑to‑end traceability from risk to design and quality activities?

With Greenlight Guru, every element of your product development is connected. You can trace the full lifecycle of a requirement, from user need to design input, design output, verification, and validation, along with associated risk management and quality records—without manual tracking.

How does Greenlight Guru support FDA and ISO requirements during product development?

Greenlight Guru is designed to help you meet regulatory expectations from day one. The platform supports structured documentation, controlled design processes, and validated workflows that align with 21 CFR Part 820 and ISO 13485 standards.

What sets Greenlight Guru apart from other platforms?

Unlike generic project or document tools, Greenlight Guru is built exclusively for the medtech industry. It brings product, quality, and regulatory teams into one purpose-built system that shortens development cycles, reduces risk, and supports global compliance from concept to launch.

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Ultralight vs Ketryx

A complete quality solution that works for your whole team

You’re building a medical device and moving fast. You don’t need a full QA team, just a system that fits your workflow and keeps you compliant. Ketryx looks dev-friendly, but it lacks full QMS coverage and takes months to configure. Ultralight by Greenlight Guru is fast, flexible, and the only complete QMS built for product teams - and supported by regulatory experts.