Risk Management Workshop

 

Date: 31 October 2018
Location: Crowne Plaza Tel Aviv
General Information
Duration: 1 - Day Course
Hours: 9:00 – 17:00
Price: 1,950 NIS + VAT
Credit Points: 2
SKU: 18897
Course Language: Hebrew
About the Course
Risk management is a critical element of the life-cycle of any medical device that spans from concept of design to postmarket surveillance. Regulators expect that risk management be inherently built into the Quality Management System (QMS) of medical device companies by using the life-cycle approach to implement risk management tools according to the elements of ISO 14971 and the requirements of ISO 13485:2016. Employing risk management from the start will help the company save time and money and will reduce exposure after commercialization of a medical device.

This risk management workshop is designed to help participants understand the importance and purpose of ISO 14971 and identify links between ISO 13485:2016 and ISO 14971. It will also demonstrate how risk management applies to the product life-cycle and how to effectively implement the objectives of a risk management process. By using interactive hands-on workshop and group discussion, participants may develop the knowledge and skills necessary to understand the risk management process and the risk management steps.
Who should attend
  • Managers and personnel of medical device companies involved in regulatory affairs, quality management, R&D, manufacturing, service, marketing  
  • Team members from medical device startups
Risk Management Workshop
Benefits to the Participants
On completion of this workshop, participants will be able to: 
  • Identify the links between ISO 13485:2016 and ISO 14971
  • Explain how risk management relates to the product lifecycle
  • Define risk management terminology
  • Outline the stages of the risk management process
  • Define the key deliverables of the risk management process
Contact us
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Issues to be covered
  • Key risk management terms & definitions
  • Overview of ISO 14971
  • Risk management requirements in ISO 13485:2016
  • Using risk management as a tool during design & development
  • Applying a “risk-based approach” to all QMS processes

About The Lecturer

Ms. Bosmat Friedman

Bosmat Friedman is the Head of Clinical & Regulatory Services of ProMedoss. She has been working as a regulatory consultant since 2007 initially as a consultant in Push-Med and subsequently as the CEO of MJ RAC.
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Mr. Hezi Erez

Senior QMS Project Manager
Hezi has 28 years of experience in the hi-tech industry and more than 16 years in the Medical Device QMS field. Hezi held a number of managerial positions (VP & Director, Manager roles) in companies such as Alpha Omega Engineering, novoGI and LabStyle Innovations.
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Ms. Shoshana Friedman

Shoshana (Shosh) Friedman is the President and CEO of ProMedoss, Inc. Shosh has more than 20 years of experience in the fields of regulatory affairs, clinical trials, and quality assurance of medical devices and biotechnology.
For more information please click here


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