New Course Offering: Introduction to ISO 14971
Introduction
Risk management is a cornerstone of medical device development and regulatory compliance. ISO 14971:2019 provides a structured framework for identifying hazards, assessing and controlling risks, and monitoring the effectiveness of risk mitigation measures throughout the device lifecycle. For therapeutic goods manufacturers, biotechnology companies, and testing laboratories, a strong understanding of ISO 14971 is essential for ensuring patient safety, regulatory compliance, and successful product launches.
QSN Academy is now offering the course Introduction to ISO 14971, designed specifically to equip professionals with practical knowledge and tools to implement risk management in line with ISO 14971 and ISO 13485 requirements. This course is particularly suited for quality, operations, design and development, and R&D teams seeking to enhance their competence in risk management practices.
Course Overview
The Introduction to ISO 14971 course provides a practical, case-based approach to mastering risk management for medical devices. Participants learn to execute the risk management process with confidence, integrating ISO 14971 requirements into design, development, and production activities. The course emphasises both theoretical understanding and applied skills, ensuring attendees can implement risk management effectively within their organisations.
Key learning outcomes include:
Developing Risk Management Plans (RMP) and Risk Management Files (RMF)
Addressing risks associated with device safety, design, and foreseeable misuse
Managing residual risks and evaluating overall device risk prior to product launch
Aligning risk management with ISO 13485 design and development stages
Tracking residual risks throughout production and post-market surveillance
Learning Modules
The course content is structured into comprehensive modules that cover every aspect of risk management under ISO 14971. These modules provide a sequential understanding of risk management principles and their practical application:
Foundations: Understanding why risk management matters and its link to ISO 13485
The ISO 14971 risk management process
Top management responsibilities in risk management
Competence requirements for risk teams
Risk Management Plan (RMP) creation and documentation
Risk Management File (RMF) establishment
Risk analysis techniques
Identifying risks associated with intended use and foreseeable misuse
Evaluating device safety risks
Recognising hazards and hazardous situations
Risk estimation and evaluation methodologies
Implementation of risk controls
Assessment of residual risks
Benefit-risk analysis and control evaluation
Determination of overall residual device risk
Risk management review processes
Integration of risk management in production and post-production stages
Application of risk management tools, including PHA, FMEA, FMECA, FTA, HAZOP, and use-error analysis
These modules are designed to be interactive, with real-world case studies illustrating how risk management principles apply to simple and complex medical devices. Participants gain hands-on experience in evaluating and mitigating risks across the device lifecycle.
Target Audience
The course is intended for professionals who play a pivotal role in medical device quality, regulatory compliance, and product development. This includes:
Quality managers and staff responsible for QMS implementation
Operations personnel involved in device manufacturing and production planning
Design and development engineers seeking to integrate risk management into stage-gates
R&D teams developing new medical technologies
Regulatory affairs specialists preparing for device submissions and inspections
The course is particularly valuable for start-ups or organisations transitioning into medical device production, where establishing compliant risk management processes from the outset is critical.
Practical Benefits
Participation in the Introduction to ISO 14971 course provides multiple tangible benefits:
Enhanced Competence: Participants acquire the knowledge to implement risk management processes correctly and confidently.
Regulatory Readiness: The course prepares teams for ISO 13485 audits, notified body inspections, and other regulatory submissions.
Operational Efficiency: Integrating risk management into development and production processes reduces the likelihood of errors, product recalls, and nonconformities.
Improved Documentation: Attendees learn to create well-structured RMPs and RMFs that satisfy regulatory expectations and demonstrate due diligence.
Practical Application: Real-world examples and case studies reinforce learning, ensuring participants can apply techniques directly to their work environment.
Course Delivery and Expertise
The course is delivered by Dr. Kathy Walsh, Principal Consultant and Director at QSN, who brings over 24 years of experience in the pharmaceutical, medical device, and biotechnology industries. Dr. Walsh has extensive expertise in GMP, ISO 13485, ISO 14971, ISO 17025, and general quality management systems. Her practical approach, combined with a deep understanding of regulatory expectations, ensures that participants receive training grounded in real-world applications.
QSN Academy provides flexible delivery options tailored to organisational needs, including group training for teams, face-to-face sessions, and supplementary support for integrating learning into daily operations. This flexibility ensures that the course can address specific industry challenges while enhancing overall staff competency in risk management.
Why Choose This Course
Medical device companies face increasingly stringent regulatory requirements, and the ability to demonstrate effective risk management is critical to market access and patient safety. The Introduction to ISO 14971 course empowers teams to implement a structured risk management process, align with ISO 13485, and meet regulatory expectations with confidence. By providing both theoretical knowledge and practical tools, the course helps organisations avoid common pitfalls, reduce residual risks, and strengthen their overall quality systems.
For organisations seeking to upskill staff, improve audit readiness, and integrate risk management seamlessly into product development and manufacturing processes, this course offers an essential foundation.
Contact Us to Find Out More
QSN Academy’s Introduction to ISO 14971 course is a scientifically grounded, practical training program designed to equip medical device professionals with the skills needed to implement effective risk management. By attending this course, participants gain a clear understanding of ISO 14971 principles, learn to manage risks throughout the device lifecycle, and ensure compliance with regulatory standards.
For therapeutic goods manufacturers, biotechnology companies, and testing laboratories, this course represents a critical investment in staff development, regulatory readiness, and the safe delivery of medical devices. Enrolment in this program ensures that teams are not only compliant but also confident in their ability to manage device risks effectively.
