Medical Device QMS Software — Qualio

MEDICAL DEVICE COMPLIANCE

Medical device compliance, automated

Design controls, risk management, and multi-framework compliance in one platform. AI agents handle gap analysis and regulatory monitoring so your team ships devices.

Medical device quality management system software for modern challenges

Challenge

Many medical device companies work across multiple systems that create a siloed approach to quality management.

Some have a home-brewed CAPA approach, or a separate tool for design controls. Others are stuck in paper-based systems that clutter and complicate quality.

These approaches don't scale. And they slow down the release of the innovative, life-saving products your patients need.

Solution

Qualio replaces your legacy systems with centralized, cloud-based medical device QMS software that's accessible from anywhere.

Flexible workflows and templates give you room to mature and scale your quality processes with your business.

And design controls, documents, training and more are all handled in a consistent way - all underpinned by powerful reporting and audit trailing for complete visibility.

Medical device quality management system software for prototype to production

Guarantee quality with easy-to use QMS software for medical devices that grows with your company
Digitize your document stack and share information quickly and easily
Execute workflows for document approval, design controls, training and more
Manage suppliers, audits and change control across your entire business in real time

Have confidence in your medical device QMS

Unlock complete visibility of your medical device QMS landscape, from design controls to outstanding training
Pull design elements from Jira, TestRail and more straight into Qualio
Find the information you need in seconds from a single source of truth
Generate release documentation, from ISO 14971 risk assessments to user requirements and Change History Reports, with a single click

Successfully navigate complex regulations

Easily comply with ISO 13485, ISO 14971, the MDSAP, FDA 21 CFR Part 11/820 and more
Seamlessly weave risk management into your design and development activities for a right-first-time approach
Build a clear audit trail and end-to-end traceability for all product information
Get expert advice from our best-in-class quality advisors

Medical device QMS resources

Medical device quality management software datasheet

Learn how Qualio arms your business with a holistic, compliant medical device eQMS - from design controls to document management

ISO 13485 toolkit

Download our toolkit to access a range of ISO 13485 resources.

Get a clause-by-clause compliance checklist, an audit readiness guide, a design controls e-book, a certification guide and more

Trusted by medical device companies worldwide

Hear from our customers

"We passed our MDSAP recertification audit with Qualio!"

John P.

Quality Assurance Manager, KUBTEC Medical Imaging

"Qualio is a superb eQMS solution for medical devices."

Andrew R.

Director of Tech & Quality, Medbaye

"The validation documentation provided by Qualio was easy to understand and execute. I really like the in-app support and chat function."

Soni M.

QA/RA Director, NovoSource

"I would recommend Qualio to small companies implementing a quality system for the first time. Qualio helped us reduce our workload and our paper trail."

Paul M.

CEO, Arann healthcare

"We evaluated all players on the market and came up with Qualio as the best balance of price, capability, and quality of support."

Jeffrey B.

CFO, FifthEye

"Qualio enabled us to seamlessly work through our 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 H.

CEO, Surfatek

"Qualio+ fits right in to ensure a smooth transition to an eQMS. The team offered excellent advice every step of the way."

Chris S.

Quality Manager, CureMetrix

"A digital trail is so important in medical devices, particularly around field servicing and updating. It's just lovely to know that you have these automatic links and alerts, and that two years from now when you're looking back, you will find it.

"###### Andrew L.