ISO 14971:2019 Risk Management for Medical Devices

Date: Two consecutive days, to be advised | Time: 11:00 AM – 3:00 PM NZT (Two Half-Day Sessions)
Cost: NZD 950 | Format: Online

Master the fundamentals of ISO 14971:2019 and its impact on medical device risk management. This course is designed to provide a comprehensive understanding of how risk management applies to the design, development, manufacturing, and lifecycle of medical devices.

Participants will also explore how ISO 14971:2019 integrates with ISO 13485:2016 and MDR 2017/745, ensuring risk management processes align with international regulatory expectations. Through interactive exercises and real-world case studies, attendees will learn how to apply risk management principles effectively within their organisation.

What You’ll Learn

ISO 14971 Fundamentals – Understanding the risk management framework and regulatory expectations
Risk Management in Practice – How to apply risk management within a Quality Management System (QMS)
MDR & IVDR Compliance – Understanding risk management in the context of EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
ISO/TR 24971 & Annexes – How to interpret and apply guidance documents for practical implementation
Risk Analysis & Evaluation – Identifying, evaluating, and mitigating risks throughout the medical device lifecycle
Risk Control & Residual Risk Assessment – Ensuring patient safety while maintaining compliance
Post-Market Risk Management – Integrating production and post-production activities into a risk management framework

Who Should Attend

This training is ideal for professionals involved in quality, regulatory affairs, risk management, engineering, software development, and medical device manufacturing. Whether working with traditional medical devices or Software as a Medical Device (SaMD) / Software in a Medical Device (SiMD), participants will gain essential knowledge for implementing effective risk management strategies.

Course Format

Two half-day sessions (April 9 and 10, 11:00 AM – 3:00 PM NZT)
Live online training with expert instructors
Interactive exercises and case studies tailored for practical application
Internationally recognised BSI Certificate upon completion

Meet Your Trainer

This course is led by Anne Arndt, a regulatory expert specializing in Software as a Medical Device (SaMD), quality compliance, and international medical device regulations. With extensive experience in both the European and New Zealand regulatory landscapes, Anne brings a wealth of knowledge from multiple jurisdictions, ensuring a comprehensive understanding of global requirements.

With over 20 years of experience, she has guided medical device manufacturers through the complexities of regulatory compliance, quality systems, and product approvals. Before moving to New Zealand, Anne worked extensively in Europe, helping companies implement risk management strategies, comply with international standards, and navigate approval processes in multiple markets. As the Director of Johner Institute New Zealand, she continues to assist companies in New Zealand and Australia, leveraging her expertise in medical technology development, regulatory consulting, and quality system optimization.