The Only Quality Management Software Made Exclusively for Medical Device Companies

Bring safe and compliant devices to market in less time and for less money


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A Quality Management Software Platform that allows you to...

Automate Quality Processes

Build quality management into your design and development processes instead of waiting for QA to catch issues when they are more expensive and difficult to fix.


Follow FDA/ISO Best Practices Automatically

Being the only eQMS built exclusively for medical device companies, FDA and ISO best practices are built into every feature. Now you can feel confident that your work is aligned with the latest regulations.


Have Instant Traceability Without Mistakes

Save time and money by ditching time-consuming paper and spreadsheet-based traceability matrices. automates traceability so your employees and consultants can focus on activities that help you get to market.


Collaborate With Fewer Emails and Meetings

Collaborate and communicate in real-time within the same platform the work is being done. Your team will waste less time holding unnecessary meetings, searching email threads and communicating across multiple messaging apps.


Everything you need to achieve compliance, audit readiness and visibility
into your processes

Design Control Software

A hassle-free way to document your design controls while maintaining full traceability.

  • Connect your team and entire product development process in one always accessible place
  • Simplify compliance by providing the necessary traceability documents and records on demand
  • Eliminate non-value add documentation and reporting activities
  • Generate Design History Files (DHF) without having to search for the required documentation

Learn more about design control >

“There have been less groans over
documentation. There is a more tangible link
between risk and design controls.
I am much
more confident in our documentation

and believe it will make our upcoming premarket
submission much less painful.”

Michelle Zwernemann,
Director of Product Development
Infinite Biomedical Technologies


Risk Management Software

Incorporate risk management into every stage of your design and development process.

  • Keep an always up-to-date risk management file throughout your product’s lifecycle
  • Comply with ISO 14971 and other industry standards by using the first solution to map its features directly to these standards
  • Visualize the relationships between requirements, risks, and the verification tests that mitigate these risks
  • Avoid costly rework by identifying, mitigating and preventing potential risks early in your development process.

Learn more about risk management >


“ has made it significantly
easier to get documentation reviewed
and approved
and to explain the function
of design controls and risk management
to management.”

Rian Wendling,
Director of Regulatory Affairs


Document Management Software

Manage your controlled documents, records, and SOPs in one convenient place.

  • Save time and get organized with e-signatures, automated document routing, revision control, and more
  • Ensure your team is always working off the most current version of a document
  • Find required documentation during audits and inspections without chasing down stakeholders and missing or lost documents

Learn more about document management >


“Our employees are 'document averse', so
minimizing any of the tedious tasks
that are purely about documentation is important.”

Kate Montgomery,
Lead R&D Scientist
Zebra Medical Technologies


More powerful features to manage your quality and compliance

Integrated Quality Processes
Real-Time Visibility
User Dashboard
Unlimited Projects & Users
Required FDA & ISO Documents
Dynamic Reporting
Electronic Signatures
Unified Management Dashboard
Live Workflow Status
Export Data
Role Based Security

Customer Success & Launch Services

Our experts can help you understand regulations and use to launch safer products in less time.


Customer Success Expert

Navigate the process of launching your product in a regulated market with the help of our medical device experts.

More about consulting services >

Launch Packs

Get running sooner. Your quality management system is set up for you and we'll even implement your forms, procedures, and templates.

More about launch packages >

Concierge Onboarding

Get your whole team trained and using the software in only hours rather than months with our hands on, customized concierge onboarding services.

Learn more about concierge onboarding >

Consulting Services

Confused by the regulatory process? Not sure how to best set up your eQMS? Struggling to make risk
management a part of your entire product lifecycle? We can help.

Regulatory Compliance Consulting

Our gurus are medical device professionals that have helped hundreds of companies achieve and maintain regulatory compliance.

More about consulting services >

Quality Management Consulting

We can help you setup your new eQMS, or help you improve your current Quality Management system and processes.

More about consulting services >

Regulatory Submission Consulting

If you're looking to bring a new device to market, we can help you determine the best path and help you achieve 510(k) clearance or CE Marking.

More about consulting services >

Speak with a medical device quality management expert and see in action.

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Next: Learn about Design Control Software