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Wed, 10 Apr


Virtual Event

Introduction to Medical Device Risk Management - Online Live Training (Hebrew)

Discover the crucial link between risk management and the safety of medical devices in our comprehensive training. Gain the tools to ensure compliance, reliability, and user trust, safeguarding the future of healthcare innovation.

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Introduction to Medical Device Risk Management - Online Live Training (Hebrew)
Introduction to Medical Device Risk Management - Online Live Training (Hebrew)

Time & Location

10 Apr 2024, 9:30 am – 1:00 pm GMT+3

Virtual Event

About the event

Risk management is crucial for medical device manufacturers as it ensures the safety, reliability, and compliance of their products, fostering trust among users and minimizing potential harm. 

This comprehensive training equips you with the basic tools and insights to navigate and mitigate risks effectively according to ISO 14971.

Elevate your expertise and safeguard the future of healthcare innovation.


09:30   – 10:30

- Regulatory   Requirements

- Key Definitions and Concepts

- The Risk Management Lifecycle

- Risk Management Planning and Design Control Integration

10:30   - 11:30

- Risk Analysis and Evaluation:

  • Preliminary   Hazard Analysis (PHA)
  • PHA Exercise 1

11:30   – 11:45


11:45   – 12:45

- Risk Analysis and Evaluation:

  • Risk Evaluation
  • PHA Exercise 2

- Risk Control

- Risk Management Summary Report

- Post Production Control



Intended for: Employees and managers of medical device companies: CEOs, quality and regulatory managers, design and product managers, engineers.

About the trainer:

Helit Dovrin - Executive Consultant, Coach, Auditor and Lecturer worked for more than 25 years as Quality and Regulatory Senior Leader at the world leading medical device companies such as: Philips Healthcare, GE Healthcare, Align Technology and Biosense Webster part of Johnson & Johnson.

Helit gained experience & expertise in all areas of the Quality Management System and Regulatory Affairs including FDA & Notified Body Inspection Management, ISO-13485, EUMDR & MDSAP Compliance Audits, and Quality & Safety escalations.


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