About Applying ISO14971 & IEC62304 2018
Applying ISO14971 and IEC62304 - A guide to practical Risk Management is organized between 27 Mar and 28 Mar 2018.
The Applying ISO14971 and IEC62304 - A guide to practical Risk Management (Applying ISO14971 & IEC62304 2018) will take place at Hilton Zurich Airport in Zurich, Switzerland.
There is the opportunity to uncover the newest developments in Safety, Risk Management, Medical Devices and Medical Products at this prominent Seminar.
Applying ISO14971 & IEC62304 2018 is organized three times a year.
Global Compliance Panel is the PCO of Applying ISO14971 & IEC62304 2018, Applying ISO14971 and IEC62304 - A guide to practical Risk Management.
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Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management. To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device the 'Safety Case' or 'Assurance Case' document is a well-established method to collect all safety related information together in one place. This documentation will most likely become mandatory for all devices (currently only required
Important Dates
Day 1 Schedule Lecture 1: Introduction into Risk Management and Quality System Integration Why risk management? Historical perspective International regulatory / statutory requirements Risk Management Lifecycle and stakeholders Over-reaching concept Integration into ISO13485 Lifecycle steps Risk Management Benefits Liability issues Streamlining product development Improving product safety and quality How to Implement Risk Management into ISO13485 SOP framework Planning and execution Monitoring and control Lecture 2: Risk Management to ISO 14971:2012 Risk Management Planning Risk Management Life Cycle Hazard Identification Hazard Domains Hazard Latency Issues Risk Rating Methods Initial (unmitigated) Risk Assessment Mitigation Strategies and Priorities Mitigation Architectures Alarm Systems as Mitigations Risk Control Bundles Post Mitigation Risk Residual Risk Safety Integrity Levels European special requirements (Z-Annexes) Safety Requirements Hazard Mitigation Traceability Verificat
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