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

Date: 29th March 2021 -
2nd April 2021
Time: 09:15 - 12:30
Duration: 5 virtual sessions
Venue: Online
Event details:

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.

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Delegate cancellation policy

Any cancellations received in writing up to two weeks prior to the event are refundable. All bookings are provisional until full payment is received.

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Per delegate: €495.00
(plus VAT)
Book Now
Non Member
Per delegate: €670.00
(plus VAT)
Non Member
Book Now

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