Customer Testimonials
|
|
Subscribe NewsletterIntroduction to ISO 14971: Risk Management
Product Id
:
600124
Overview: The term "Risk Based Processes" as become the latest trend in all aspects of medical device design, manufacture, test. distribution or service.
From the establishment of the Product Requirement Specification down to the service and maintenance processes, risk management is now the latest requirement in the medical device industry. Since its inception in 2000 and the amendments of 2003 the current version of ISO 14971 - Medical Devices - Application of risk management to medical devices, has been the industry standard for the establishment and implementation of a Risk management process. Whether your organization is making a simple Class I device or providing ground-breaking technology through the PMA process, the need for risk-based processes is required. This webinar will provide a basic overview of the ISO standard and provide the attendee with the basic knowledge of what is expected from an organization in regards to risk management.
From the establishment of the Product Requirement Specification down to the service and maintenance processes, risk management is now the latest requirement in the medical device industry. Since its inception in 2000 and the amendments of 2003 the current version of ISO 14971 - Medical Devices - Application of risk management to medical devices, has been the industry standard for the establishment and implementation of a Risk management process. Whether your organization is making a simple Class I device or providing ground-breaking technology through the PMA process, the need for risk-based processes is required. This webinar will provide a basic overview of the ISO standard and provide the attendee with the basic knowledge of what is expected from an organization in regards to risk management.
Areas Covered in the Session:
- A Basic overview of ISO 14971:2007 including
- Management Responsibilities
- Risk Analysis
- Risk Evaluation
- Risk Control and Risk Reduction
- Risk Management Reports
- Risk Management Files
Who Will Benefit:
- Design Engineers
- Software Engineers
- Quality Assurance Personnel
- Program Managers
- Manufacturing Engineers
- Regulatory Personnel
- Engineering Managers