Every medical device needs a benefit-risk analysis for overall residual risk evaluation, but where does one start? In this seminar you will get a step-by-step guidance on how to make a successful benefit-risk analysis.

Seminar language
Swedish, with English slide support. Any questions in Swedish/English.

Speaker
Cristina Albu Barkman, Senior Quality and Regulatory Consultant

Cristina’s expertise is broad, covering over 20 years of experience in product development, product risk management and quality assurance of complex medical devices, from startups to large multinational companies. She is the chairperson of the Swedish national standardization committee TK 355 and member of the international standardization committee JWG1, which developed the ISO 14971 standard. “An area which I am passionate about is product risk management, in which I have been working with both development of the international standard ISO 14971, as well as with practical application for different companies and wide range of products.