Modern quality management software (QMS) that unites your team, tools, and data



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Medical Device Manufacturers

Improve quality, decrease time-to-market, and reduce risk

Medical device companies need a scalable QMS that is simple to start and delivers high-quality products to market without delay or issue. Qualio has everything you need to be successful: 
  • ISO 13485 / FDA CFR Part 820 quality system
  • Design Control and risk management
  • Real-time, web-based collaboration features
Pharmaceutical R&D and Manufacturing

Unite your team, tools, and data to simplify quality and improve scalability

Manual and legacy quality system create bottlenecks as companies move from R&D to clinical trials, manufacturing, and distribution. Qualio’s QMS platform improves and automates processes to reduce complexity and support growth and scalability: 
  • Automated workflows to streamline quality management 
  • Real-time web-collaboration features
  • Reports that provide full visibility into performance 
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Contract Organizations

Apply quality-driven approaches to every stage of the life sciences supply chain

Identify, investigate, and resolve quality-related issues to improve company performance. Easily share progress and performance against KPIs to highlight wins and areas that need attention 
  • Non-conformance, deviation, complaints, and CAPA 
  • QMS processes links to change management
  • Seamless link between processes

Trusted by 100's of life sciences and
healthcare organizations all over the world.

Join customers in over 80 countries and 1,100 cities worldwide.

What customers are saying about Qualio

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Qualio helped us secure our critical ISO 13485 certification within six months of signing up we couldn't have done this without them. Going through this certification process without 'non-conformities' is like passing a difficult exam and with the highest honors. I am so proud of the team and this remarkable result.

Quality Manager, Cardiacces
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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. 

Qualio 's simple-to use-interface and automated workflows ensure high employee engagement, supporting full compliance and audit readiness. We couldn't do it without them.

Director of Quality, Dimension Therapeutics (Ultragenyx)


5 star reviews on Capterra, Getapp, and SoftwareAdvice

Consistently ranked as the quality management platform of choice by medical device manufacturers, Therapeutics companies regulated contract service providers.



Achieve end-to-end traceability

Track every change and action from beginning to end with fully integrated, closed-loop quality processes. Keep all key stakeholders informed with Qualio’s powerful reporting capabilities.

  • Smart links between records
  • Closed-loop quality processes
  • Powerful reports



Automate quality processes

Automate all quality processes with simple, guided workflows. Monitor activities and close-out processes like change control and CAPA on time, every time.

  • Step-by-step guided workflows
  • Automated reminders
  • Linked quality processes

Follow ISO/FDA best practices

Qualio is the first cloud QMS designed to incorporate the latest FDA, ISO, medical device, and therapeutics best practices. Focus on growing your business, while Qualio takes care of compliance and quality.

  • FDA 21 CFR Part 820
  • 21 CFR Part 11 Compliant
  • ISO 13485:2016 & ISO 14971

Streamline team communication

Improve collaboration and avoid unnecessary meetings, emails, and communication across apps.

  • Automated notifications and reminders
  • In-line comments
  • Collaborate globally regardless of location
Discover Your Quality Score

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