EN ISO 14971:2019 Product Risk Management
Purpose of Education
To be able to identify the hazard associated with medical devices and accessories of a manufacturer, including non-body medical diagnostic devices (IVD), to estimate and control their risks, to monitor the effectiveness of these controls is to transfer information in a way that can create a method for these devices. The requirements of the standard can be applied to every stage of the life cycle of the medical device.
Who Should Participate?
- Risk Managers
- Validation Engineers, Managers
- Design and Production Engineers,
- Project Managers involved in Design and Development
- Quality Engineers involved in validation activities
- Quality Auditors
- Due to the diversity of stakeholders including health care providers, industry, patients and citizens, especially those working in manufacturers, distributors and dealers related to medical devices.
- Quality Assurance and Quality Control engineers, managers assigned to customer complaint or Corrective Preventive Action
- Medical doctors,
Content of Education
- What are terms and recipes?
- What is risk policy? How to prepare?
- Risk Management Process Overview
- How to answer ISO / TR 24971 Annex-A Question List?
- How to prepare a risk management plan?
- What are the Risk Analysis techniques?
- In what situations are these techniques used?
- How is a risk assessment done?
- How is the information collected after production and production?
- What are the reasons for the conditions?
- What is Risk Benefit Analysis? How?
- How to review the risk management process for medical devices?
- How to write a risk management report?
- Case analysis study covering applications
- How is the process of impact of this information on risk analysis carried out?