Medical Device Risk Management Seminar (ISO 14971:2019)

Gstudy > Courses and seminars > Medical Device Risk Management Seminar (ISO 14971:2019)

Nov 11, 2026

By Sivan Luder, PhD

Cycle 16.0

Location: Frontal

Starts at: 09:30

Duration: מפגש 1

Language: עברית

This interactive training provides a comprehensive understanding of ISO 14971:2019 and ISO/TR 24971:2020, covering the application of risk management principles to medical devices throughout the product life cycle. Participants will gain practical skills to identify hazards, estimate and evaluate risks, implement risk controls, and maintain a compliant Risk Management File. The course integrates regulatory expectations from the EU MDR, FDA, and ISO 13485, with real-world examples, case studies, and practical exercises to ensure knowledge transfer into daily work.

How will I benefit?

Understand the requirements and intent of ISO 14971:2019 and ISO/TR 24971:2020
Learn to develop and maintain a Risk Management Plan, Report, and File
Identify hazards and hazardous situations effectively
Apply risk estimation and evaluation methods, including qualitative and semi-quantitative approaches
Select and verify risk control measures
Use production and post-production information to keep the risk file current
Prepare for audits and inspections by demonstrating compliance and effectiveness

Who Should Attend: Professionals working in the medical device industry, including Quality, Regulatory, R&D, Manufacturing, Engineering, and Clinical teams.

Prerequisites: Basic understanding of the medical device industry; Familiarity with regulatory concepts (helpful but not required); Experience in quality or manufacturing environments (preferred)

Date & Hours - 11.11.2026 | 9:30-15:30 | Haifa

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About Sivan Luder, PhD

Dr. Sivan Luder is a Regulatory, Clinical, and Quality Expert with a PhD in Molecular Biology and over 10 years of experience across various industries, with a strong focus on the medical device sector. Possesses a deep scientific background and extensive experience in leading the development and implementation of medical devices from concept to commercialization, managing regulatory projects, and preparing...