Risk Management requirements within ISO 13485:2016
The Irish Medtech Skillnet in collaboration with Meddev Solutions Limited is delighted to offer a one day in-depth overview of risk management concepts used throughout a Quality Management System (QMS). It focuses on the application of various risk management tools to meet the requirements within ISO 13485:2016.
The course is designed to enhance the level of understanding for those actively utilising and engaging with ISO1348:2016 and ISO14971:2012.
Background: ISO 13485:2016 has been revised to include a greater focus on risk management impacting both on the CE and QMS requirements. The course will examine each of these elements:
Overall view of ISO 14971:2012 requirements with special reference to the Z-Annexes
EN 62304: Software
EN 62366: Usability
60601: electrical safety
Infrastructure and work environment
Product recall and traceability
ISO 13485:2016 introduces the imperative for medical device manufacturers to implement a QMS that has a greater emphasis on risk throughout product realisation and process. This course for medical device manufacturers has been developed to meet this more rigorous focus on risk management.
Overview of Course Structure: This course is interactive and will use accelerated learning techniques and uses exercises to consolidate understanding. Breakout exercises will be used throughout the day to reinforce the concepts and give attendees experience in applying risk management. Candidates will be actively engaged with emphasis on questions and group discussions to further assist their understanding.
Target Audience: Quality assurance professionals, quality engineers, manufacturing engineers, Research and Design Engineers, regulatory professionals, and Internal Auditors. The content will have great value to individuals who are involved in any aspect of implementing or maintaining a QMS.
Program Objectives: Upon completion of the course, participants will further enhance their understanding of risk management, utilise the tools for effective risk management, and the risk requirements of ISO 13485:2016.