At Aurevia, Cristina supports companies from early design to post market follow-up, helping them strengthen documentation, align cross functional teams, and build a device risk management approach that truly supports safe innovation.
Cristina supports companies through:
• Hands on ISO 14971 courses and workshops
• Tailored risk management file reviews
• Benefit–risk and risk acceptability guidance
• Preparation for audits and regulatory questions
Her approach is grounded, practical, and rooted in decades of real world experience across device types. The result? Teams gain more clarity, stronger documentation, and a confident path to compliance.
“Effective risk management isn’t about static risk analysis —it is about creating a dynamic approach to risk management through the entire device lifecycle.” -Cristina Albu Barkman, Principal Consultant
If your company wants to take its device risk management to the next level, contact us to learn how we can support you in establishing efficient risk management processes that ensure device safety.