Embarking on risk management can be a daunting and confusing as risks are inherent in so many things and processes. Fortunately ISO 14971:2019 exists to provide direction and clarity.
Yet many companies struggle to connect risk management to everything else like design and development. This makes developing a risk acceptability matrix (especially with a paper-based system) extremely challenging and time consuming.
Qualio’s cloud-based quality management system connects risk management to design and development activities.
Save yourself some time and headache knowing risk management is connected to the entire product lifecycle, giving you visibility to see vulnerabilities across your entire product lifecycle and organization.
“My favorite thing is how Qualio keeps us in a constant state of audit readiness. We chose Qualio as we needed our system to be scalable to support our rapid growth and facilitate quick employee onboarding.”
“Qualio has helped make my life as a Quality Manager very easy. For the documentation side, as soon as an auditor comes in and audits, they can see everything in the audit trail. Nothing is missing, nothing can be changed without it being documented and the auditors think that is so great.”
“The changelog in Qualio has been particularly helpful. We can print it out and give it to the auditor to show we’re still compliant since we validated two years ago, for example.”