Quality Risk Management and ISO 14971 – Medical Devices

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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?... Read More

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.

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What's covered?

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  • Understanding the need for Risk Management
  • ISO14971 – detailed analysis of the requirements of the standard
  • Understanding the implications of the various revisions of ISO 14971
  • Understanding the requirement to characterize medical devices
  • Identifying possible hazards
  • Estimating the associated risk – removing subjectivity
  • Review & reduction of risk
  • Risk Management Techniques Hazards - FMECA, Fault Tree Analysis, HAZOP and Preliminary Hazard Analysis
  • How to apply Risk Management to the Product Lifecycle
  • How to apply Risk Management to all aspects of Quality and Production

Who should attend?

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  • R&D Managers and Engineers
  • Engineering / Technical / Production personnel
  • Quality Auditors

What will I learn?

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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.

Who are the tutors?

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Share this Programme

SnapshotSnapshot

Duration
1 training day
Course Times
9.00am - 5.00pm
Price
€450

(includes course documentation, lunch and refreshments).

Delivery Mode
This programme is available In-House and on certain Public dates

What They SayWhat They Say

Course was interactive which facilitated the learning. Tutor was very knowledgeable

– Caoimhe McCarthy, Quality Complaints Investigator, Cook Medical

News & UpdatesNews & Updates

Notified Body View of Implementation of EN ISO 14971:2012

During the process of harmonisation of ISO 14971: 2007 as an EN standard, it became apparent that the standard did not comply with all the requirements of the M...

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EN 14971:2012 Content Deviation #6 and #7

During the process of harmonisation of ISO 14971: 2007 as an EN standard, it became apparent that the standard did not comply with all the requirements of the M...

Read More

Quality Risk Management and ISO 14971 – Medical Devices

Duration: 1 dayPublic Price: €450
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