Product requirements live in engineering tools. Compliance documentation lives elsewhere. The gap between both creates manual transferring of data, error-prone and duplicative processes that cause delays and increase risk.
Regulated Product Lifecycle
Sync development and quality systems to keep your compliance picture current as you build.
With Qualio, compliance happens in parallel to development. Every decision updates your compliance record in real time, replacing last-minute documentation assembly with continuous evidence capture.
Regulated product companies accelerating product development with Qualio:
The problem with the status quo
When engineering and quality work in separate systems, the compliance record is always a sprint behind.
60%
faster processes to achieve 510(k) - EvoEndo
1
month cut from time-to-market - SimBioSys
20-30%
faster-time to market - CergenX
How it works
One regulatory record that updates itself as the product develops
Qualio watches development tools like Jira continuously. When an engineer marks an update, Qualio flags that change for formal review. Engineers keep working exactly as they do today.
Run a Design Review that generates your DHF documentation. Qualio identifies every change since the last review, guides reviewers through approvals and automatically generates documents.
Qualio builds a technical file that tracks every product release, files are automatically updated, tied to a specific product release and version-controlled.
Know your compliance posture against multiple standards. Qualio shows what has evidence, what is missing, and what is flagged. Controls satisfied for one standard automatically map to the next, eliminating duplicative work.
What quality and regulatory teams say
"We selected Qualio based on functionality and ease of transition. We now leverage Qualio across our entire organization."
Holly Rundle
Director of Compliance, StayinFront
"Qualio simplified things immensely."
Andrew Breite
Director of Quality Assurance, VitaCyte"We're so streamlined now. It's amazing where we were, compared to where we are now. I hope we get the same auditor in future, so I can say, look how wonderful this is now."
Ami Anderson
Director of Operations & Quality Management, NeuFit
"We now have a consolidated device file which reflects the development of our product. 18 months ago, we didn't have anything like that."
Phil Cooley
Quality Manager, Bond Digital Health"Me getting back hundreds of hours in a year thanks to Qualio is the equivalent of about one FTE."
Mike Trudnak
VP of IT & Information Security, xCures
"The validation documentation provided by Qualio was easy to understand and execute."
Soni M.
QA/RA Director, NovoSource
"My favourite thing is how Qualio keeps us in a constant state of audit readiness."
Deb G.
Director of Quality, Dimension Therapeutics
