Keep your post-market medical devices safe and compliant in any country

Use the only modern eQMS designed exclusively for medical device companies to stay ahead of FDA and ISO changes while growing your business.

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Our eQMS Software helps post-market medical device companies like yours...


Have Instant End-to-End Traceability

Forget the paper and spreadsheet-based traceability matrices. automates traceability and makes it easy to trace a CAPA all the way back to your design controls.

Automate Quality Processes

Don’t wait for QA to catch issues when they’re more expensive and difficult to fix. Avoid post-market catastrophes when quality and risk management are built into every design and development process.


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 always aligned with the latest regulations in any country you operate within.


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 manage CAPAs, customer complaints, nonconformance issues, and audits

CAPA Management

Find the root cause of CAPAs sooner and produce output reports on demand to verify resolution.


  • Easily trace CAPAs back to their root cause, even if it’s in design control.

  • See quality issue trends in real time and correct them before they become a regulatory issue.

  • Assign CAPA-related tasks to your team, include guidelines, and track everyone’s progress towards due dates.

  • Access your procedures and present them to the FDA in a couple of clicks.

Customer Complaint Management

Streamline a customer feedback and complaint processes that aligns with FDA regulations.


  • Quickly determine whether feedback requires immediate action or the issuing of a CAPA.

  • Ensure your customer complaint processes are compliant and easily audited by regulatory bodies in any country.

  • Optimize customer feedback management and oversight for faster response times.

Nonconformance Management

Reduce non-conformance cycle times and the risks associated with your device.


  • Easily capture defect details such as part, quantity, failure type, and severity.

  • Automatically adjust workflows based on risk and loop in the right team members and suppliers to resolve issues quickly.

  • Escalate the right defects to CAPAs automatically and at the right time.

Audit Management

Conduct internal and external audits, automatically route findings based on risk, and easily share results.


  • Manage tasks, follow ups, communications, and any actions that result from audit findings.

  • Automatically escalate high-risk findings for investigation and monitor low-risk findings for recurrence.

  • Create and share final audit summaries internally and externally with a single click.

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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Focus on your products and growth by taking the headaches out of managing post-market devices.

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