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.
Pre-configured templates and pre-written documentation for FDA & ISO compliance.
Access to our team of quality experts to ensure you meet and exceed your QA goals.
With Qualio’s secure and cloud-based system, paper files, folders, and spreadsheets become a thing of the past.
Prevent potential risks early and mitigate risk easily with easy risk management that complies with ISO 13485 and ISO 14971.
Create assessments, assign, report, and track training activity across your company within one platform.
Qualio’s change control software allows you to manage any change easily and effectively, ensuring compliance and audit readiness.
Seamlessly generate reports on activity across your system and your users and set periodic review cadences.
With Qualio Events, manage pre-defined actions and responses and track in accordance with regulatory requirements.