Navigate the risk management maze: Benefit-risk analysis made easy

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.

Welcome to get some breakfast from 08.30, meet our speaker and mingle with other industry colleagues.

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.

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

Note: The event is free, but space is limited. If you are not able to participate, we urge you to make a cancelation as soon as possible or assign your place to a colleague. If you register but don’t attend, you will be charged 300 SEK.