Cristina Albu Barkman Senior Quality and Regulatory Consultant
Cristina has over 20 years of experience in product development, product risk management and quality assurance of complex medical devices in the Medical Device industry, both from startups and large international companies. Cristina is perceived as communicative and professional in her roles. With her long and broad experience, she easily grasps new issues and finds constructive solutions. She is passionate, enthusiastic, well organized, with strategic thinking and a pragmatic sense for details, without losing sight of the entire context.
“Product risk management is required by the MDD for demonstration of conformity with the essential requirements. How do you recommend companies to handle this?” ”I recommend starting the risk management activities already in the initial phases of product development. Early identification of potential hazards and hazardous situations enables choice of design options for inherent safety, which is the preferred risk control option to ensure safety and performance of the device. A well performed, systematic risk management work will ensure a safe design and conformity to essential requirements.”