DESIGN CONTROLS

Get your medical device
to market faster

Pull your device design data together and stamp out risks.
Focus on building a great medical device - without the
headache of manual compliance work.

 

A smarter way to manage design controls

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Challenge

Quality teams work in one system. Engineering teams in another.

Siloed and disconnected teams and platforms make traceable, compliant product development impossible to manage.

Work grinds to a halt, quality and development work against each other, and your path to market becomes a complex nightmare.

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Solution

Qualio Design Controls offers a single source of truth for all your product development activities.

Pull product data into Qualio with integrations. Control inputs, requirements and risks. Bring your quality and engineering teams into sync.

All underpinned by a complete, compliant document stack to show your auditors.

Unite systems and data to enable effective collaboration and stop delays

  • Demolish quality and engineering siloes by connecting systems like Jira, Azure DevOps and TestRail to Qualio
  • Build a real-time, always-up-to-date document stack that flows seamlessly from your engineering team to quality 
  • Centralize all design control data by product, from requirements to inputs, outputs, risks and drag-and-drop attachments
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Maintain end-to-end traceability across systems in real time

  • Easily pinpoint missing tests, risk mitigations and more for a right-first-time approach
  • Drive changes and product updates quickly and easily
  • Unlock 100% traceability across design elements while your engineering teams work in the source systems they know and love
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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, e-signatures and objective evidence
  • Access automated snapshots of product documentation for each stage of your product lifecycle
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Purpose-built for your quality and product teams

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Quality teams

for medical device, SaMD and SiMD companies enjoy a single source of truth for design controls and product data.

Export automated documentation, embed FMEA and ISO 14971 risk management and unlock complete traceability from input to output.

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Product teams

enjoy uninterrupted development as the engineering systems they're used to are linked directly to Qualio.

Develop and innovate, safe in the knowledge that your work is flowing accurately and in real time straight to the quality department.

Design controls management resources

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Ultimate guide to medical device design controls

Become a design controls expert and start applying the 9 core elements of medical device design controls with our comprehensive breakdown guide.

Get my guide
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Design controls datasheet

Learn how Qualio Design Controls combines powerful functionality with ease of use for a controlled, compliant pathway to market that meets ISO and FDA requirements.

Get my datasheet

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

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Document management

Make paper, filing cabinets, folders and spreadsheets a thing of the past. 

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Risk management

Detect and mitigate risks and comply with
ISO 14971 and ICH Q9.

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Supplier management

Control and categorize suppliers and third parties with complete visibility.

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Training management

Build a competent, confident, compliant, continuously improving workforce.

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Change control management

Manage change activity easily and effectively with complete traceability.

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Audit management

Make compliance and audit readiness the natural core of your business DNA.

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CAPA & NCR management

Build automated response workflows for any quality event. 

Don't just take our word for it!

Hear from our many happy customers

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"Qualio is the best QMS cloud-based system I have ever seen."
Paul H.
Senior VP of Ops, Tech & Quality, Advantice Health
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"When I recommend Qualio, one of the first things I say is: you're going to be able to get this thing in-house, validated, implemented and live in a short amount of time with limited resources.
That's unique in this industry."
Becki N.
Quality & Regulatory Lead, Synthego
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“Qualio has helped make my life as a quality manager very easy.”
Gene V.
Quality Manager, Cirris
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"I joined in November. I contacted Qualio 2 weeks later. We went live mid-December. We had all users working in the system by January. And we had our ISO 13485 certification by July.

Without Qualio, we'd never have done that."
Karen H.
Head of Quality & GxP Compliance, 30 Technology
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"We’ve been able to show certain clients what we’ve accomplished with Qualio, and they were very impressed.

The VP of Quality for a client company said, "If I could build from the bottom up, I’d do it exactly the way you guys did it"."
Stephana P.
VP of Quality, Alphazyme
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"There are other eQMS providers that are very well-established, but not particularly accessible to organizations that don't have the fundamental basics in place.

Qualio is not overly complicated. It gives us those foundational aspects of a quality system in a way that people can actually get behind."
Phil C.
Quality Manager, Bond Digital Health
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"The perfect QMS system for a start-up. Everything, from validation to migration and training, was a positive experience."
Drew M.
Director of Quality, ECM Therapeutics
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"Me getting back hundreds of hours in a year thanks to Qualio is the equivalent of about one FTE. 

Qualio has given us one more staff member in a company where we throw nickels around like manhole covers!"
Mike T.
VP of IT & Information Security, xCures
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“The cost of our Qualio licences is insignificant compared to what we've saved by just improving our processes.”
Peter B.
Director of QA, Watchmaker Genomics
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"The Qualio team made a big difference to our company by providing amazing help and guidance at a critical time in our QMS development."
Jackie L.
Managing Director, Auxilio Pharmaceuticals
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"Set-up is easy and very user-friendly.  Qualio gets rid of the paperwork. Simple to use, affordable."
Rachel A.
Medical Outreach Specialist, eHealth Technologies
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“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.
CEO, FifthEye
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“Once you understand how Qualio works, it's really easy to plan out processes and put them into place within the QMS.”
Sara V.
Quality Manager, Leaseir Technologies
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"My favourite thing is how Qualio keeps us in a constant state of audit readiness."
Deb G.
Director of Quality, Dimension Therapeutics
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"Any intelligent person would look at Qualio and say, "This is exactly what a cloud-based system should do". But when you actually see it in action, you still think it's pretty cool."
Andrew L.
CEO, ArcScan
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"A game-changer for a paper-heavy QMS. Qualio is a breath of fresh air."
Gareth Q.
Director of Quality, iMIX
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"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
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"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
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"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
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"We passed our MDSAP recertification audit with Qualio!"
John P.
Quality Assurance Manager, KUBTEC Medical Imaging
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"Qualio has been great to work with. We implemented an entire QMS with them! Intuitive functionality, friendly staff."
Kim K.
Executive VP of Operations, VirTrial
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"A big step up for our small company. Much easier than digging through a file repository manually!"
Matt S.
Senior Software Engineer, ArcScan
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"Now that we’re electronic, we can grow to 500 or 1,000 employees.
Since we don’t need to grow the QA team as much, we can put more resources into employees who make us money, like scientists and manufacturing personnel."
Adolfo R.
Director of Information Systems & Data Compliance, IRISYS
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"With other vendors, we felt like just a number.
But this is like a true partnership. Qualio has definitely changed our world."
Eric D.
Director of Quality Assurance, Expression Therapeutics
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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
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Initially, we didn't have anyone on the quality side.

The support Kelly and the team gave us at the beginning was great and we were really leveraging them to build out our QMS from scratch.

It was so streamlined, it was so efficient, they were super helpful and communicative.

That's exactly what we needed - and that's why we went with Qualio.
Heather U.
CEO, EvoEndo
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"Qualio shows we're taking quality seriously and investing in quality improvement initiatives.

We plan to keep growing with Qualio, offering visibility, continuous improvement and knowledge management to our current and potential customers."
Edgar G.
Quality Assurance Specialist, The Dot
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