Course Description

ISO 13485 2016 (Virtual)

ISO 13485 2016 (Virtual) is a course run by SQT Training Ltd, Dublin. It is a 'Online Learning' course with a duration of 1 day. For more information about ISO 13485 2016 (Virtual) at SQT Training Ltd, please review the details below.

ISO EN 13485:2016 is the global harmonized Quality Management Systems Standard used by medical device manufacturers to meet certain requirements to support the safety and effectiveness of the products they sell into Europe. ISO EN 13485:2016 was published on 26th February 2016 and has now completed its transition period since April 2019.

This Standard specifies requirements for a Quality Management System (QMS) that can be used by an organisation involved in one or more stages of the life cycle of a medical device including the design & development, production, storage & distribution, installation, servicing & final decommissioning & disposal of medical devices.

It can be used by external parties to assess the organisations ability to meet customer & regulatory requirements or Notified Bodies can use this standard when assessing whether companies have a QMS, which supports the European Directive/Regulation requirements. Such an assessment is required where a manufacturer seeks to apply the CE mark. This means that personnel within this industry must be conversant in the ISO EN 13485:2016 requirements, if they are certified to this standard.

The ISO 13485 2016 (Virtual) course at SQT Training Ltd is listed in's national courses finder.
Training ProviderSQT Training Ltd
Course LocationLimerick
Course TypeOnline Learning
Course Start Date12th May 2020
Course End Date12th May 2020
Course Duration1 day
Course TimeCourse broken down 1 x 2hrs, 1 x 1.5 hrs and 1 x 1.5 hrs
Course Fee€350
Phone061 339040
For more information about SQT Training Ltd, please visit our College page on by clicking here.

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SQT Training Ltd

Callan Centre Castletroy, National Technology Park, Various Locations around Dublin, Dublin, Republic of Ireland

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