Risk Identification Techniques for medical devices

#iso14971 #riskassessment #riskidentification ISO 14971 forces medical device manufacturers to think about all the characteristics that could affect safety. But how do you demonstrate that you have "thought of all characteristics"? How do you make sure that no risks were missed? How do you argue that you have successfully completed the task of risk identification? In this talk, we will use examples to explore various methods of risk identification and demonstrate how digital tools can make this process simple and efficient. Presented by: Karl Larsson, MSc, MBA, Technical File Specialist and co-founder of Aligned AG Content: 0:00 Introduction 2:06 Process of Risk management 2:35 Structured risk identification approach 3:35 Hazardous Situation 4:33 Two General Methods 5:53 Risk Identification Sources 12:15 Hazard Category List 16:45 FMEA (Component analysis) 19:53 HAZOP (Hazard and Operability Study) 24:50 ISO 14971:2012 Annex C Questions 27:20 Analyse User Needs and Design Input 29:42 Honorable Mentions 32:48 Summary This recording was broadcasted during an Aligned Sharpen your Skills event. Start a free trial: https://www.aligned.ch/free-trial Visit our website: https://www.aligned.ch Connect on Linkedin:   / aligned-ag