Course Description

Quality Risk Management and ISO 14971 (Medical Devices) (Virtual)



Quality Risk Management and ISO 14971 (Medical Devices) (Virtual) is a course run by SQT Training Ltd, Dublin. It is a 'Online Learning' course with a duration of One day. Quality Risk Management and ISO 14971 (Medical Devices) (Virtual) gives a Course Qualification of Level 1 Certificate. For more information about Quality Risk Management and ISO 14971 (Medical Devices) (Virtual) at SQT Training Ltd, please review the details below.

ISO 14971 was updated in 2007, updated in 2009 and now updated again in 2012. Why all these changes and what are the implications for you the manufacturer? How far does applying ISO 14971 go in ensuring compliance with the medical devices directives? What does ISO 14971 contain and where, how and when should I apply it?
These and other questions will be answered by this informative one day course on ISO 14971. The course covers the regulations governing risk management for medical devices and the practical implementation of risk management from design through manufacture, distribution and use, through to post market feedback.

Participants achieve the following learning outcomes from the programme;

State the differences between the various revisions of ISO 14971 and the implications that these have for the manufacture of medical devices.

  • Interpret the regulations pertaining to Risk Management and ISO 14971 in particular.
  • Identify and quantify risks associated with medical devices.
  • Decide on the acceptability of those risks.
  • Re-evaluate risks following corrective action.
  • Apply various risk assessment techniques such as FMECA, Fault Tree Analysis and HAZOP.
The Quality Risk Management and ISO 14971 (Medical Devices) (Virtual) course at SQT Training Ltd is listed in Courses.ie's national courses finder.
Training ProviderSQT Training Ltd
Course LocationLimerick
Course TypeOnline Learning
Course QualificationLevel 1 Certificate
Course Start Date23rd July 2020
Course End Date23rd July 2020
Course DurationOne day
Course Time9.00am - 5.00pm 23rd July 2020 22nd October 2020
Course Fee395
Phone+ 00353 61 339040
For more information about SQT Training Ltd, please visit our College page on Courses.ie by clicking here.

Course Provider

SQT Training Ltd



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

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