The all-in-one medtech product & compliance hub
Ultralight simplifies the confusing and time-consuming aspects of building a modern medical device.
The
all-in-one medtech product & compliance hub
Ultralight simplifies the confusing and time-consuming aspects of building a modern medical device.
The
all-in-one medtech product & compliance hub
Ultralight simplifies the confusing and time-consuming aspects of building a modern medical device.
The all-in-one medtech product & compliance hub
Ultralight simplifies the confusing and time-consuming aspects of building a modern medical device.
Built and trusted by medtech innovators
Built and trusted by medtech innovators
Built and trusted by medtech innovators
HOW IT WORKS
Requirements Management
Built for the velocity of modern hardware and software development
Built for the velocity of modern hardware and software development
Intuitive Design Control
Quickly iterate and collaborate on your product design using AI-powered requirements management, and generate your Design History File with ease
Effective Risk Mitigation
Perform ISO 14971 risk management, and trace risks to design inputs for full traceability of mitigation. Configure risk management to your organization’s needs
Enhanced Traceability
Intuitive end-to-end traceability, from risks to requirements to testing in user-friendly views that put Excel to shame
Test Management
Manage test procedures and executions against approved procedures seamlessly
Intuitive Design Control
Quickly iterate and collaborate on your product design using AI-powered requirements management, and generate your Design History File with ease
Effective Risk Mitigation
Perform ISO 14971 risk management, and trace risks to design inputs for full traceability of mitigation. Configure risk management to your organization’s needs
Enhanced Traceability
Intuitive end-to-end traceability, from risks to requirements to testing in user-friendly views that put Excel to shame
Test Management
Manage test procedures and executions against approved procedures seamlessly
Intuitive Design Control
Quickly iterate and collaborate on your product design using AI-powered requirements management, and generate your Design History File with ease
Effective Risk Mitigation
Perform ISO 14971 risk management, and trace risks to design inputs for full traceability of mitigation. Configure risk management to your organization’s needs
Enhanced Traceability
Intuitive end-to-end traceability, from risks to requirements to testing in user-friendly views that put Excel to shame
Test Management
Manage test procedures and executions against approved procedures seamlessly
Intuitive Design Control
Quickly iterate and collaborate on your product design using AI-powered requirements management, and generate your Design History File with ease
Effective Risk Mitigation
Perform ISO 14971 risk management, and trace risks to design inputs for full traceability of mitigation. Configure risk management to your organization’s needs
Enhanced Traceability
Intuitive end-to-end traceability, from risks to requirements to testing in user-friendly views that put Excel to shame
Test Management
Manage test procedures and executions against approved procedures seamlessly
Quality Management
Designed for the usability and flexibility of modern quality needs
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
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
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
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.
Compliance Management
Manage compliance beyond ISO 13485
Checklist Templates
Get started with checklist templates to help you conform to common standards like ISO 14971, IEC 62304, ISO 11137, and more
Integrated Evidence
Link and actively manage evidence via the integrated quality and requirements management system
Project Management
Assign owners, understand compliance statuses, and generate declarations of conformity with ease
Create a hazard analysis in minutes
An AI copilot built for medtech
Built for the velocity of modern med-tech product development
Write more effective requirements
Create a hazard analysis in minutes
Create a hazard analysis in minutes
Ensure rigorous test procedures
Create a hazard analysis in minutes
An AI copilot built for medtech
Built for the velocity of modern med-tech product development
Write more effective requirements
Create a hazard analysis in minutes
Create a hazard analysis in minutes
Ensure rigorous test procedures
Create a hazard analysis in minutes
An AI copilot built for medtech
Built for the velocity of modern med-tech product development
Write more effective requirements
Create a hazard analysis in minutes
Create a hazard analysis in minutes
Ensure rigorous test procedures
Create a hazard analysis in minutes
An AI copilot built for medtech
Built for the velocity of modern med-tech product development
Write more effective requirements
Create a hazard analysis in minutes
Create a hazard analysis in minutes
Ensure rigorous test procedures
VALUES
The Ultralight Difference
The Ultralight Difference
The Ultralight Difference
Data Flexibility
We want you to stay on Ultralight because we have the best product, not because you are stuck. We make it easy to export all of your documents and data.
Data Flexibility
We want you to stay on Ultralight because we have the best product, not because you are stuck. We make it easy to export all of your documents and data.
Data Flexibility
We want you to stay on Ultralight because we have the best product, not because you are stuck. We make it easy to export all of your documents and data.
Scalability Without Complexity
Ultralight simplifies the complex ops behind medtech compliance - audit trails, validation, versioning, document generation, traceability - so you can focus on building.
Scalability Without Complexity
Ultralight simplifies the complex ops behind medtech compliance - audit trails, validation, versioning, document generation, traceability - so you can focus on building.
Scalability Without Complexity
Ultralight simplifies the complex ops behind medtech compliance - audit trails, validation, versioning, document generation, traceability - so you can focus on building.
Configurability with Defaults
We provide validated templates to help teams get started quickly, and also provide flexibility to customize key workflows because we know that no two medtech companies are the same.
Configurability with Defaults
We provide validated templates to help teams get started quickly, and also provide flexibility to customize key workflows because we know that no two medtech companies are the same.
Configurability with Defaults
We provide validated templates to help teams get started quickly, and also provide flexibility to customize key workflows because we know that no two medtech companies are the same.
TESTIMONIALS
What our early adopters are saying
What our early adopters are saying
What our early adopters are saying
What our early adopters are saying
We exist to solve our customers problems, so the best validation of the work we're doing is positive feedback from medtech innovators.
We exist to solve our customers problems, so the best validation of the work we're doing is positive feedback from medtech innovators.
We exist to solve our customers problems, so the best validation of the work we're doing is positive feedback from medtech innovators.
Dustin Kasel
Head of Engineering, Brevitest
“Until we came across Ultralight we had resigned ourselves to the limitations other e-QMS packages provide, which meant most of our engineering documentation happened in siloes. It was clear from our initial interactions with Ultralight that they wanted to do things differently. The flexibility provided by Ultralight’s solution is unprecedented!”
Gautam Sadarangani
CTO & COO, Tenzr Health
“The way we design and develop medical devices has not changed in the last 50 years, while our medical devices have grown more complex and dynamic. Ultralight is the only solution that helps modern engineering teams think through and manage the complexity, thereby increasing development speed and ensuring regulatory compliance.”
Stephen Restaino
CEO at Sonosa Medical
"Though often daunting for a startup, Ultralight has made establishing a robust, efficient QMS straightforward allowing us to maximize our focus on innovation. Ultralight's intuitive design made it effortless to learn for our entire team, regardless of experience level. For our most experienced team members, the UI represents an industry leading approach to simplifying otherwise rote, time-consuming tasks. Ultralight's responsive team also ensured a seamless integration process, tailored to our needs.”
Edgardo Romero
Director of Quality, Brevitest
“We needed to switch our QMS, but our main concern was the integrity and time commitment of data migration. Ultralight made it seamless by offering automated migration capabilities that saved us hundreds of hours and helped us maintain our document versioning scheme. Even after onboarding, the team has continued to deliver new capabilities at a rapid pace that sets them apart! Overall, we find Ultralight to be user friendly, flexible, and with excellent capabilities that made the switch well worth it.”
Already have a QMS?
No problem! We can automate your data and document migration to have you up and running in days.
Already have a QMS?
No problem! We can automate your data and document migration to have you up and running in days.
Already have
a QMS?
No problem! We can automate your data and document migration to have you up and running in days.
Already have
a QMS?
No problem! We can automate your data and document migration to have you up and running in days.
Stats
Time is your most valuable resource.
We help you save a ton.
Time is your most valuable resource
We help you save a ton
Time is your most valuable resource
We help you save a ton
Ultralight is built for the velocity of modern product development. Everything we do is optimized to save you time so that you can focus on building a high quality product.
17%
17%
Faster product cycles
22%
22%
Reduction in quality costs
2h
2h
Hours to get up and running
FAQs
I don’t need all of the functionality that Ultralight provides. Can I just use a few features?
Yes! We have the ability to modularize our platform into various configurations.
How long does onboarding take?
Even if you have existing product data and quality documentation, we can have you up and running within hours.
Does Ultralight provide validation documentation?
Yes! Ultralight does the heavy lifting and comes validated with appropriate validation evidence.
I like the way I work right now. Can I customize Ultralight to my needs?
Absolutely. Ultralight enables configurability so that you can tailor key workflows to your unique needs.
This sounds amazing, but how much does it cost?
Ultralight offers some of the friendliest pricing for organizations. Most customers who have switched from existing software vendors have saved 20% on costs!
How easy is it to get data into and out of Ultralight?
Ultralight believes that customers should own their data. Unlike traditional QMS/PLM vendors, we have bulk import and export capabilities so that you actually and practically own your data.
Still have questions?
If you can’t find an answer to your question here, contact us and we’ll get back to you ASAP.
FAQs
I don’t need all of the functionality that Ultralight provides. Can I just use a few features?
Yes! We have the ability to modularize our platform into various configurations.
How long does onboarding take?
Even if you have existing product data and quality documentation, we can have you up and running within hours.
Does Ultralight provide validation documentation?
Yes! Ultralight does the heavy lifting and comes validated with appropriate validation evidence.
I like the way I work right now. Can I customize Ultralight to my needs?
Absolutely. Ultralight enables configurability so that you can tailor key workflows to your unique needs.
This sounds amazing, but how much does it cost?
Ultralight offers some of the friendliest pricing for organizations. Most customers who have switched from existing software vendors have saved 20% on costs!
How easy is it to get data into and out of Ultralight?
Ultralight believes that customers should own their data. Unlike traditional QMS/PLM vendors, we have bulk import and export capabilities so that you actually and practically own your data.
Still have questions?
If you can’t find an answer to your question here, contact us and we’ll get back to you ASAP.
FAQs
I don’t need all of the functionality that Ultralight provides. Can I just use a few features?
Yes! We have the ability to modularize our platform into various configurations.
How long does onboarding take?
Even if you have existing product data and quality documentation, we can have you up and running within hours.
Does Ultralight provide validation documentation?
Yes! Ultralight does the heavy lifting and comes validated with appropriate validation evidence.
I like the way I work right now. Can I customize Ultralight to my needs?
Absolutely. Ultralight enables configurability so that you can tailor key workflows to your unique needs.
This sounds amazing, but how much does it cost?
Ultralight offers some of the friendliest pricing for organizations. Most customers who have switched from existing software vendors have saved 20% on costs!
How easy is it to get data into and out of Ultralight?
Ultralight believes that customers should own their data. Unlike traditional QMS/PLM vendors, we have bulk import and export capabilities so that you actually and practically own your data.
Still have questions?
If you can’t find an answer to your question here, contact us and we’ll get back to you ASAP.
FAQs
I don’t need all of the functionality that Ultralight provides. Can I just use a few features?
Yes! We have the ability to modularize our platform into various configurations.
How long does onboarding take?
Even if you have existing product data and quality documentation, we can have you up and running within hours.
Does Ultralight provide validation documentation?
Yes! Ultralight does the heavy lifting and comes validated with appropriate validation evidence.
I like the way I work right now. Can I customize Ultralight to my needs?
Absolutely. Ultralight enables configurability so that you can tailor key workflows to your unique needs.
This sounds amazing, but how much does it cost?
Ultralight offers some of the friendliest pricing for organizations. Most customers who have switched from existing software vendors have saved 20% on costs!
How easy is it to get data into and out of Ultralight?
Ultralight believes that customers should own their data. Unlike traditional QMS/PLM vendors, we have bulk import and export capabilities so that you actually and practically own your data.
Still have questions?
If you can’t find an answer to your question here, contact us and we’ll get back to you ASAP.
FAQs
I don’t need all of the functionality that Ultralight provides. Can I just use a few features?
Yes! We have the ability to modularize our platform into various configurations.
How long does onboarding take?
Even if you have existing product data and quality documentation, we can have you up and running within hours.
Does Ultralight provide validation documentation?
Yes! Ultralight does the heavy lifting and comes validated with appropriate validation evidence.
I like the way I work right now. Can I customize Ultralight to my needs?
Absolutely. Ultralight enables configurability so that you can tailor key workflows to your unique needs.
This sounds amazing, but how much does it cost?
Ultralight offers some of the friendliest pricing for organizations. Most customers who have switched from existing software vendors have saved 20% on costs!
How easy is it to get data into and out of Ultralight?
Ultralight believes that customers should own their data. Unlike traditional QMS/PLM vendors, we have bulk import and export capabilities so that you actually and practically own your data.
Still have questions?
If you can’t find an answer to your question here, contact us and we’ll get back to you ASAP.
CONTACT US
Let’s innovate together!
Let’s innovate together!
If you’re ready to supercharge your processes with drastically better tooling, we’d love to collaborate.
If you’re ready to supercharge your processes with drastically better tooling, we’d love to collaborate.
If you’re ready to supercharge your processes with drastically better tooling, we’d love to collaborate.
© 2024 Ultralight Labs
© 2024 Ultralight Labs
© 2024 Ultralight Labs
© 2024 Ultralight Labs