Quality Risk Management and ISO Medical Devices هذه الدورة تدرس باللغة الإنجليزية

تفاصيل الدورة

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.

Learning Outcomes

On successful completion of this training course, delegates should be able to:

• 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.

Course Programme

• 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.