ISO 13485 compliance management made easy

Conquer ISO 13485 complexity with a modern software designed for all teams. Ultralight's robust quality management system offers ISO 13485 compliance simplification, allowing you to focus on cutting costs and boosting innovation for your medical devices.

Stay ahead of the competition with an intuitive solution made with innovators like you in mind. Get access to checklist templates for common standards, integrated evidence management, and more. Book your demo today!

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ISO 13485 Compliance

Document & Change Control

A document and change control system that's flexible to your needs. Use your preferred document types, versioning schemas, and change order flows, and we'll handle the rest including FDA CFR Part 11-compliant digital signatures.

Training

Implement training quizzes and automate training activities by configuring training policies with user groups. Easily understand missing trainings across your org to ensure compliance.

Suppliers

Set custom policies to ensure that you're only working with approved suppliers.

Quality Events

Fully configurable workflows to manage repeated processes like CAPAs, nonconformances, and complaints. We also provide basic templates to help teams get started!

Parts & Inventory Management

Easily ensure that the right parts are used, properly accounted for, and meet quality standards.

Document & Change Control

Training

Implement training quizzes and automate training activities by configuring training policies with user groups. Easily understand missing trainings across your org to ensure compliance.

Suppliers

Set custom policies to ensure that you're only working with approved suppliers.

Quality Events

Fully configurable workflows to manage repeated processes like CAPAs, nonconformances, and complaints. We also provide basic templates to help teams get started!

Parts & Inventory Management

Easily ensure that the right parts are used, properly accounted for, and meet quality standards.

Document & Change Control

Training

Implement training quizzes and automate training activities by configuring training policies with user groups. Easily understand missing trainings across your org to ensure compliance.

Suppliers

Set custom policies to ensure that you're only working with approved suppliers.

Quality Events

Fully configurable workflows to manage repeated processes like CAPAs, nonconformances, and complaints. We also provide basic templates to help teams get started!

Parts & Inventory Management

Easily ensure that the right parts are used, properly accounted for, and meet quality standards.

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