We simplify Quality Management so your team can focus on innovation

Qualio unites your teams, processes, and data so your organization can get products to market quickly and scale successfully.

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Our eQMS is built on the 12 Pillars of Quality

With Qualio, your organization can grow through all 12 Pillars of Quality as you scale - including premarket activities, registration, and regulatory compliance while in-market.

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  • Document Control
  • Training
  • Design Controls
  • Supplier QA
  • Risk Management
  • Complaint Handling and Feedback
  • Corrective and Preventive Action (CAPA)
  • Change Control
  • Non-Conformance Reporting (NCR) and Deviation
  • Internal Audit
  • Management Review
  • Equipment Management and Calibration

Our platform conforms with the
world’s regulatory bodies



Ensure compliance

Qualio is built to make FDA 21 CFR Part 820, 21 CFR Part 11, ISO 13485 & 14971 audit-readiness easy for your team. While your competitors are wrestling with regulatory bodies, you’ll zip through compliance and move to streamline systems for bigger profits.


Get to market faster

Qualio is easy to use and provides the real-time feedback capabilities you need across a distributed workforce, accelerating your time to market. By generating revenue sooner, you’ll have more capital to grow faster than other players in the market.


Scale effortlessly

Qualio is flexible enough to grow with your team. That means you won’t have to replatform in the middle of the crucial startup and scale-up stages. While the other companies burn months moving from one rigid QMS to another, you’ll take a lead that will be hard to overcome.


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.


Life sciences and healthcare organizations trust Qualio across the world.

Qualio is trusted across industries

We work with teams across life sciences to ensure they bring safe and effective products to market.

Barbara Y
Barbara Young
Senior Quality Manager | Proscia

We especially liked Qualio’s history management that tracks changes to procedures and documents, and the configurable organization of documents that could be applied to demonstrate regulatory compliance

Medical device

From De Novo applications to 510(k) and PMA, Qualio works with medical device teams across all stages of their business.

Pharma & biotech

Our platform enables pharma and biotech companies to organize NDAs / ANDAs, supplier management, change control, and more.

Contract research and manufacturing organizations (CRO & CMO)

Qualio’s platform helps companies conform to GxP compliance and saves CROs and CMOs time and money in the regulatory process.

Software as a Medical Device (SaMD)

SaMD teams using Qualio file for MDSAP and 510(k), conduct internal audits, comply with ISO audits, and manage design control.

Learn why customers love Qualio

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Where do you rank on Quality?

Where do you rank on Quality?

Outstanding quality management is the common thread among companies that are successful at avoiding regulatory issues and adept at getting to market quickly.