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