Medical Device Risk Management - Online Live Training (Hebrew)

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 tools and insights to navigate and mitigate risks effectively according to ISO 14971.

Elevate your expertise and safeguard the future of healthcare innovation.

Agenda

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

Break

11:45   – 12:45

- Risk Analysis and Evaluation:

• Risk   Evaluation
• PHA   Exercise 2

- Risk   Control

- Risk   Management Summary Report

- Post   Production Control

12:45-13:00

Q&A

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.