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Risk Management for Medical Devices
Mandatory requirements for Risk Management in the Design, Development and Manufacturing of Medical Devices are defined in ISO 13485:2003 and ISO 14971:2007 standards. The ISO 14971:2007 was also recognized by the FDA as a Consensus Standard for Risk Management. The Risk Management process allows identifying Risks during the different stages of the Design & Development and taking the appropriate action...Continue reading
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Issues to be covered
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Basic Definitions and Glossary for Risk Management
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The different Regulatory Requirements
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What to do – Detailed requirements and stages
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How to do it – Templates , Documentation and Tools
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When to do – Synchronization with the Design Control and Device Life Cycle
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Interaction with the Quality System and the Design Control
Who should attend
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Design & Development Managers, Project Managers and Development Teams involved in Development of Medical Devices
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QA Managers and QA persons accompanying the Design & Development process
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QA persons who wish to specialize in Design Control for Medical Devices
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Entrepreneurs who intend to Develop a Medical Device
Benefits to the Participants
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Practical tools for understanding and execution of the Risk Management Process
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Integration of the Risk Management process with the Design Control and the Device Life Cycle
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Utilization of the Risk Management outputs for Design Verification
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Templates and computerized tools for the Risk Management process
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Compliance with the different Regulatory Requirements
About The Lecturer
