Risk Management for Medical Devices

Conducted by: Mr. Gadi Shtepel
Categories: Medical Devices
SKU: 19216
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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

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 to eliminate the Risks or reduce them as much as practical. Monitoring of the Risks is going on during the Life Cycle of the Device using feedback from the field and Risk Assessment before any change in the Device.

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Date:  25 November, 2019
Course location: Kfar Maccabiah, Ramat Gan
Duration: 1-Day Course
Hours: 09:00 - 17:00
Credits: 1
Course Language: עברית

Course price: ₪1,850 + VAT
Early registration is Closed
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Issues to be covered

  • Basic Definitions and Glossary for Risk Management
  • The different Regulatory Requirements
  • What to do – Detailed requirements and stages
  • How to do it – Templates , Documentation and Tools
  • When to do – Synchronization with the Design Control and Device Life Cycle
  • Interaction with the Quality System and the Design Control

Who should attend

  • Design & Development Managers, Project Managers and Development Teams involved in Development of Medical Devices
  • QA Managers and QA persons accompanying the Design & Development process
  • QA persons who wish to specialize in Design Control for Medical Devices
  • Entrepreneurs who intend to Develop a Medical Device

Benefits to the Participants

  • Practical tools for understanding and execution of the Risk Management Process
  • Integration of the Risk Management process with the Design Control and the Device Life Cycle
  • Utilization of the Risk Management outputs for Design Verification
  • Templates and computerized tools for the Risk Management process
  • Compliance with the different Regulatory Requirements

About The Lecturer

Gadi Shtepel
Gadi Shtepel brings with him over 35 years of experience in
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