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.

Have quality and regulatory experts on your side

  • Save time and resources by utilizing our expert quality team.
  • Get up and running quickly and through validation in record time.
  • End-to-end concierge service from SOPs, gap assessments, to internal/supplier audits and more.

Learn more about Qualio Plus >>

Purpose-built for Both Quality & Product 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 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.

Don’t take our word for it

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Qualio’s Design Controls feature has been an important element of our product development and regulatory approval processes.

Kevin Harris
President, CureMetrix

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.

Sara V
G2 Review

Any questions we had around setup [or processes] were answered very quickly indeed. great to be able to have proper traceability around the document-based processes.

Joseph O
G2 Review

I use Qualio for DHRs, SOP, forms, training, design history files, document control, storage for drawings, etc. I like how easy Qualio is to find documents and ensuring only the latest is available. Also the validation is very good.

Gary Lynch
Quality consultants

See other features that make Qualio the #1 Top Rated Cloud QMS.

Document Management

Training Management

Risk Management

Change Control

CAPAs & Nonconformances

Audit Management

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