Quality Training

Risk Management concepts and tools to meet the requirements within ISO 13485:2016

The Irish Medtech Skillnet in collaboration with AlphaMed Consulting and Compliant Md is delighted to offer in-depth training of risk management concepts used throughout a Quality Management System (QMS). It focuses on the application of various risk management tools to meet current requirements. The course is designed to enhance the level of understanding for those actively utilising and engaging with ISO1348:2016 and ISO14971:2019. The delivery can accommodate two day direct classroom delivery or by virtual method using appropriate media interface e.g. Zoom or Teams.


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 with specific focus on ISO 14971:2019

Overall view of ISO 14971:2019 requirements with special reference to the Z-Annexes
EN 62304: Software
EN 62366: Usability
60601: electrical safety
10993: Biocompatibility
Infrastructure and work environment
Product realisation
Virtual manufacturing
Product recall and traceability

Overview of Course Structure
This course is interactive and will use accelerated learning techniques and uses exercises to consolidate understanding. Break-out 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.

Who should attend

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.

Programme Objective

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.

Upcoming dates:


Online , Online
29 March - 2 April 2021 (9:15 - 1:30) 5 virtual online sessions
Book now


Risk Management concepts and tools to meet the requirements within ISO 13485:2016

Training Days

2 Day

Training Location

Available nationally, based on demand

Course Cost

IMDA Skillnet Member: €495
Non-member rate: €670
* Cost quoted per person