Accelerate your product development with robust Design Controls software

Qualio's Design Controls feature is built on ISO 13485 and CFR 820, in harmony with ISO 14971. The platform surfaces quality and safety impacts and produces output documentation in one-click, so your medical device team can focus on building great products.

The #1 solution that solves today's challenges



Within Medical Device companies, Quality teams work within one system, and Product teams work within another. Those systems often do not speak to one another.  Siloed teams and systems make traceability and compliant releases impossible to manage. Without a single source of truth, work grinds to a halt, opening teams to risk and hindering innovation.



Qualio Design Controls unites your team’s systems in your QMS, making Qualio the single source of truth for all of your product development activities. Design Controls enables end-to-end traceability and ISO 14971 and FMEA risk assessment, allows you to easily identify gaps, and generates your release documentation with one click.

Unite systems and data to enable effective collaboration and reduce delays

  • Eliminate Quality and Engineering siloes by connecting systems like Jira, Asana, Github and more to Qualio.
  • Ensure all documentation flows seamlessly from your Engineering team to your Quality team. 
  • Run design review meetings with ease as all your data is organized in one place and is linked to a specific product.

Maintain end-to-end traceability across systems in real time

  • Easily pinpoint missing tests, risk mitigations, and more before you release.
  • Identify new or changed items and perform Change Control on them with one click.
  • Maintain traceability across design elements while your Quality and Engineering teams work in their source systems.

Generate release documentation with one click

  • Easily produce quality documentation to ensure you’re delivering a safe and effective product, eliminating time-consuming paper-based processes and manual governance.
  • Be 100% audit-ready at all times with documentation, signatures, and objective evidence. 
  • Automated snapshots of product documentation for each stage of your product lifecycle.

Purpose-built for Both Quality & Product Teams


Quality teams

Quality teams for medical device or software as medical device (SaMD) products use design control as a single source of truth for product data. It’s fully traceable across your product systems.

With automated output documentation, fully compliant risk management (FMEA, ISO 14971) and Part 11 compliant e-signatures and change control, quality team can do their work better. 


Product teams

Product teams for medical device or SaMD products enjoy uninterrupted development as source systems (like Jira) are linked directly to the quality system in Qualio.

Get the flexibility to focus on your current development model, whether that’s Agile, Waterfall, or otherwise and know it’s linking back to meet quality requirements.


Have quality and regulatory
experts on your side

Add Qualio+ to any plan and receive expert quality assurance
support to help growing companies get to market faster.

Regulatory content

Pre-configured templates and pre-written documentation for FDA & ISO compliance.


Quality assurance experts

Access to our team of quality experts to ensure you meet and exceed your QA goals.

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 Cochran
Executive Director of Quality, Linical Americas
“Qualio has helped make my life as a Quality Manager very easy. For the documentation side, as soon as an auditor comes in and audits, they can see everything in the audit trail. Nothing is missing, nothing can be changed without it being documented and the auditors think that is so great.”
Gene Vought
Quality, Cirris
“Having everything in one place. That you can connect or link documents to other documents and keep the traceability of any changes made or decisions made.”
Dragan Velickovski
Software Engineer, Axiom
“Qualio has made it so much easier to review and edit documents prior to document release. This has improved the quality of our documentation and reduced the amount of time spent on getting documents through our release process.”
User in Medical Devices
”I like the very flexible approach that Qualio offers to deal with document type of information. A document can be basically everything from an SOP, over an HR file to an Equipment log. This is very powerful in particular in combination with the tagging feature.“
Christian S
Consultant CMC + QA
“The best thing I like about Qualio is how simple the documents are prepared for easy understanding by anyone who has no knowledge on what they're reading, be it a policy or a basic learning document.”
Sravya D
Medical Fulfillment Specialist

See other features that make Qualio
the #1 top rated cloud QMS


Document management

With Qualio’s secure and cloud-based system, paper files, folders, and spreadsheets become a thing of the past.


Risk management

Prevent potential risks early and mitigate risk easily with easy risk management that complies with ISO 13485 and ISO 14971.


Training management

Create assessments, assign, report, and track training activity across your company within one platform.


Change control

Qualio’s change control software allows you to manage any change easily and effectively, ensuring compliance and audit readiness.


Audit management

Seamlessly generate reports on activity across your system and your users and set periodic review cadences.


CAPAs & Nonconformances

With Qualio Events, manage pre-defined actions and responses and track in accordance with regulatory requirements.


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