Aurevia expert spotlight: 3 questions with our risk management expert
Meet Cristina Albu Barkman, Principal Consultant, and one of Aurevia’s most experienced specialists in medical device risk management. With more than 25 years in QA/RA and nearly two decades dedicated specifically to risk management across complex systems, software, hardware, and single use devices, Cristina brings both depth and clarity to a challenging field.
Here are three quick questions we asked her:
1. What excites you most about working with risk management today?
-Risk management is a powerful framework that has evolved from a compliance checkbox to a strategic tool that strengthens patient safety, product quality, and cross functional collaboration.
2. What is the most common challenge you see manufacturers struggle with?
-Recurring issues include defining risk acceptability criteria, managing benefit–risk assessments, and maintaining a living risk management file that reflects real world post market insights — and these are all areas that I frequently support through the trainings that I lead and in my consultancy work.
3. What part of your role do you find most rewarding?
-It’s helping teams feel confident — whether it’s by guiding companies through complex regulatory safety requirements or clarifying ISO 14971 standard clauses so they can make informed, safe decisions throughout the device lifecycle.
We’re proud to have Cristina driving excellence in patient focused, compliant, and effective risk management at Aurevia.
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.
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