Bring FDA and ISO-compliant medical devices to market…

...In less time, for less money, and without the risk of an audit going sideways.

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Our eQMS software helps pre-market medical device companies like yours...


Get Instant Traceability

Ditch the paper and spreadsheet-based traceability matrices. automates traceability so your employees can focus on activities that get you to market.

Automate Quality Processes

Don’t wait for QA to catch issues when they’re more expensive and difficult to fix. Have quality management built into your design and development processes from the start.


Follow FDA/ISO Best Practices

This is the only eQMS that has FDA and ISO best practices specific to medical device companies built into every feature. You’ll know your work is aligned with the latest regulations.


Streamline Team Communication

Stop wasting time on unnecessary meetings, long email threads, and managing communication across apps. In, collaboration and communication happens where your team works.

It’s everything you need to achieve compliance, audit readiness, and visibility into your processes

Design Control & Traceability

Maintain full design traceability by creating and updating your traceability matrix in minutes, not hours or days.

With, you can create your design control objects, link complex configurations, and attach related documents with a single click.

  • Connect your team and development in one always accessible place.

  • Easily provide traceability documents and records on demand.

  • Eliminate non-value add documentation and reporting activities.

  • Generate Design History Files without searching 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

Integrate risk management into your entire quality management system right out of the box.

You’ll spend less time and money fixing issues that expose you to risk when you can catch them earlier and have complete visibility.

  • Only cloud-based risk management solution that aligns with ISO 14971

  • Keep your risk management file up to date throughout your product’s lifecycle.

  • Stay compliant by using the first solution to map its features to all major standards.

  • Visualize the relationships between requirements, risks, and verification tests.

  • Avoid costly rework by identifying, mitigating, and preventing potential risks.

Learn more about risk management →

“ has made the design control and risk management process extremely easy to understand and explain to people not familiar with the process and helped them to understand how all of the steps are linked.”
Rian Wendling Director of Regulatory Affairs SimplicityMD

Document Control

With, managing signatures, documents, audits, and inspections is a breeze.

No more chasing signatures, manually routing documents, working off the wrong version, and sweating audits. Everything is easily accessible and in one place.

  • Save time and get organized with Part 11 compliant e-signatures, auto document routing, revision control and more.

  • Know that 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 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

Pre-Market QMS Software

Launch compliant devices faster and for less money

Our pre-market software package is everything you need to design and launch safe and compliant medical devices.

You’ll be able to document design controls, maintain full traceability, integrate risk management into everything you do, and get your documents and signatures under control.

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Post-Market QMS Software

Keep your device safe and compliant post-launch

Our post-market software package helps to keep your device safe and compliant after it’s in your user’s hands.

You can quickly find the root cause of any CAPA (even trace it back to your design control), manage feedback in the way the FDA requires, better handle non-conformance issues, and ensure audits come to a quick and favorable conclusion.

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Expert Services

Get pre and post-market help from our expert team

Our services ensure you’re able to remain 100% focused on developing and selling your medical devices.

Whether you’re pre or post-market, our in-house team of medical device experts can help implement in record time, navigate the changing compliance landscape, set up your processes and systems, train your team, and more.

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Start accelerating your time to market today.

Get the platform you need to bring safer medical devices
to market faster, with less risk.

 Schedule My Free Demo