Accelerated product development that doesn't sacrifice quality

Build products faster with an eQMS purpose-built for software as medical device (SaMD) organizations. Qualio unites your teams and systems in one collaborative environment
while keeping you compliant with IEC, ISO and FDA regulations.

eQMS for software as a medical device (SaMD) companies



For SaMD teams, building with velocity and delivering quality are often opposing forces.

With engineering teams in one system and quality teams in another, balancing speed and compliance throughout the product lifecycle is nearly impossible.



Qualio harmonizes your teams in a single source of truth so it’s easy to manage traceability, auditability and compliance without complicating your route to market. 

Get your SaMD product to market quickly without sacrificing oversight and quality.

Speed up your release cycle

  • Integrate systems like Jira, Azure DevOps, TestRail and more for better collaboration
  • Easily connect data via API to centralize your product design data
  • Execute guided workflows for drafting, reviewing, approving, and retiring documents

A quality platform your team will want to use

  • Straightforward implementation makes onboarding your team fast and easy
  • Generate key release documentation like requirements traceability and risk analysis matrices with one click
  • Assign training based on roles and responsibilities, including in-line assignments

Slice risk from your development process

  • Drive robust closed-loop quality within your company with end-to-end traceability across your design and development tools
  • Drill into your product lifecycle data to tackle risks and demonstrate control to your auditors
  • Set periodic review cadences to conform to FDA, IEC and ISO requirements

Software as medical device quality management resources

SaMD quality management software datasheet

SaMD quality management software datasheet

Learn how Qualio empowers your business with a complete, compliant and controlled SaMD quality management system.

Get my datasheet

9 ways to improve quality in medical device product development

Maximize quality, dodge common mistakes, embed real compliance.

Get my guide

Don't just take our word for it!

You can look at an SOP in Qualio, see the list of associated documents, and click hyperlinks to retrieve information immediately. That’s one feature I’m greatly enjoying.
Tyler C
Executive Dir. of Quality, Linical Americas
“The Validation documentation provided by Qualio was easy to understand and execute. I really like the in-app support chat function. It is easy to get in touch with the Qualio team with questions or concerns and the team responds quickly."
Soni M
Director QA/RA, NovoSource
My favorite thing is how Qualio keeps us in a constant state of audit readiness. We chose Qualio as we needed our system to be scalable to support our rapid growth and facilitate quick employee onboarding.
Deb Glancy
Director of Quality
“Qualio enabled us to seamlessly work through the ISO 13485:2016 requirements and design errors out of our quality management system. One way Qualio achieves this is to ensure that changes flow through our system and are applied globally.”
David Hughes
CEO, Surfatek
“Qualio has been super helpful to us feeling like we have all the pieces in place for quality management an FDA standard.”
Jen Baird
CEO, Fiftheye
“We evaluated all players on the market ... and came up with Qualio as the best balance of price, capability, and quality of support. Really like the change event management, API flexibility, training tracking, and customer success support.”
Jeffrey B
CFO, Fiftheye

Popular Content for Software as
Medical Device Professionals


Regulatory Expectations for Software as a Medical Device (SaMD) Startups

To ensure that products are safe and effective for use, medical device manufacturers need to follow specific guidelines enforced by the U.S…

Customer Story

Proscia Uses Qualio to Bring High-Quality Medical Device Software to Pathologists Around the World

Since 2014, Proscia has been building software solutions for pathology and cancer research. The company recently decided to apply their software... 


How to Manage the Med Device Software Development Process in Your eQMS

Managing the medical device software development process is a big undertaking. Software as a device is regulated like any other medical device, but...


Learn why we have been ranked the quality management platform of choice