Quality risk management software for stress-free audits

Proactively identify, mitigate, prevent and resolve risks before they happen in a dedicated risk management platform

Risk management software solutions to give your business confidence

Challenge

Risks lurk in every nook and cranny of your business. Pinpointing and tackling every single one is extremely difficult. And when you do get a risk management system in place, it doesn't always integrate with your product design and development processes - leaving crucial risks undetected and unresolved as you get to market.

Solution

Qualio's risk software embeds risk management into the heart of your product design and development activities. Total visibility, bespoke action workflows and automated document stack creation removes the effort and headache of risk management and lets you bring a safe, compliant product to your patients and customers.

Detect vulnerabilities across your entire organization

• Build a single source of truth for risk identification, monitoring and remediation
• Save time and money by identifying risks early in product development
• Connect your quality and product teams in a single risk assessment software environment that keeps risk-based thinking front and center

Unlock deep risk visibility with an acceptability matrix

• Define your risk criteria then apply them across a connected risk management software platform
• Link risks to your product development design control and documentation processes to squash risks for a right-first-time approach
• Seamlessly access risk analysis and traceability matrices with one click

Embed ISO 14971 and FMEA

• Use our ISO 14971 software to embed lasting compliance into your medical device design controls
• Show complete FMEA-based risk control to your auditors
• Export risk records and link risks to CAPA plans and Qualio documents