Process Validation (PV) for Medical Device Industry

Medical Device Risk Management – ISO 14971:2019 and ISO/TR 24971:2020

This interactive training provides a comprehensive understanding of ISO 14971:2019 and ISO/TR 24971:2020 and the application of risk management principles throughout the medical device product life cycle.

Participants will gain practical skills in identifying hazards, estimating and evaluating risks, implementing risk controls and maintaining a compliant Risk Management File.

The course integrates regulatory expectations from the EU MDR, FDA and ISO 13485 through real-world examples, case studies and practical exercises.

This seminar is part of the full Medical Device Quality and Regulation Course.

Course Details

Duration: 1 day
Date: 11.11.2026
Hours: 09:30–15:30
Location: gstudy Center, Haifa

What You Will Learn

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

Who Should Attend?

Professionals working in the medical device industry, including:

• Quality and Regulatory
• R&D and Engineering
• Manufacturing
• Clinical teams

Prerequisites

• Basic understanding of the medical device industry
• Familiarity with regulatory concepts is helpful but not required
• Experience in quality or manufacturing environments is preferred