ISO 14971:2007 Application of Risk Management to Medical Devices Foundation Course

This training is designed to provide you a comprehensive introduction to the key elements of Risk Management for Medical Devices.

ISO 14971 is a key standard that specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.  The requirements of this standard are applicable to all stages of the life-cycle of a medical device.

Topics:

• Background of ISO 14971
• General Requirements
• Risk Analysis
• Risk Evaluation
• Risk Control
• Evaluation of overall residual risk acceptability
• Risk Management report
• Production and post-production information

This course is comprised of learning sessions and interactive workshops.  A post assessment shall be given and meeting the minimum requirement will be the basis for being awarded a certificate of successful completion of the course.

This course aims to give you a practical foundation in the relationship between risk management, the regulatory requirements and your quailty system.
Upon completion of this course, you are expected to:

• Understand the key elements required for the management of risk as specified in ISO 14971:2009
• Describe the relationship between risk management and regulatory requirements
• Appreciate the relationship between risk management and quality management system requirements.
• Gain experience analyzing and evaluating risk in a workshop environment

This course is relevant to manufacturers of medical devices, including IVDs, particularly staff and managers in areas of quality, regulatory affairs, technical managers, and those responsible for technical files.

Participants are expected to have basic knowledge of ISO 9001:2008 and ISO 13485:2003 quality management system standards prior to attending this course.

Note:   SGS shall provide only generic information and advice which are freely available in the public domain.

SGS will not provide company-specific advice towards any development and implementation of managements systems for eventual certification, which contravenes requirements of the IAF Guidance (i.e. provision of consultancy services).