Medical Device Risk Management: Transition to EN ISO 14971 ...
ISO 14971: Application of Risk Management to Medical Devices · 2020-04-29 Fact Sheet Risk...
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Medidee Services SA Chemin de Rovéréaz 5 1012 Lausanne | Switzerland PHONE I +41 21 311 20 59 EMAIL I [email protected] WEB I www.medidee.com 2020-04-29 Fact Sheet Risk Management.docx ISO 9001 & ISO 13485 Certified company TMP11-Training FactSheet | Rev. 3.0 | 21.02.2020 ISO 14971: Application of Risk Management to Medical Devices Duration: 2x3 hours Date & Schedule: 29-30.04.2020 9h – 12h30 Training objectives: • To understand the importance of performing risk management throughout the product lifecycle • To understand the regulatory context of ISO 14971:2019 with MDR/IVDR and other standards • To learn risk management terminology and to apply appropriate risk management techniques • To outline the stages of the risk management process and to define key deliverables Training content: • Introduction to performing risk management throughout product lifecycle o Motivations o Regulatory context o Key definitions • Use of appropriate risk management techniques o Preliminary Hazard Analysis o Fault Tree Analysis o Failure Mode Effect (and Criticality) Analysis • Preparation of Risk Management File o Risk Management Plan o Benefit – Risk Analysis o Risk Management Report Price: CHF 600 / EUR 600 Location: Online Training – Registration details will be communicated to the participants Contact & registration: [email protected]
Transcript of ISO 14971: Application of Risk Management to Medical Devices · 2020-04-29 Fact Sheet Risk...
Medidee Services SA Chemin de Rovéréaz 5 1012 Lausanne | Switzerland
PHONE I +41 21 311 20 59 EMAIL I [email protected] WEB I www.medidee.com
2020-04-29 Fact Sheet Risk Management.docx ISO 9001 & ISO 13485 Certified company TMP11-Training FactSheet | Rev. 3.0 | 21.02.2020
ISO 14971: Application of Risk Management to Medical Devices
Duration: 2x3 hours Date & Schedule: 29-30.04.2020 9h – 12h30
Training objectives:
• To understand the importance of performing risk management throughout the product lifecycle • To understand the regulatory context of ISO 14971:2019 with MDR/IVDR and other standards • To learn risk management terminology and to apply appropriate risk management techniques • To outline the stages of the risk management process and to define key deliverables
Training content:
• Introduction to performing risk management throughout product lifecycle o Motivations o Regulatory context o Key definitions
• Use of appropriate risk management techniques o Preliminary Hazard Analysis o Fault Tree Analysis o Failure Mode Effect (and Criticality) Analysis
• Preparation of Risk Management File o Risk Management Plan o Benefit – Risk Analysis o Risk Management Report
Price: CHF 600 / EUR 600 Location: Online Training – Registration details will be communicated to the participants Contact & registration: [email protected]
