Risk management is a process that involves the identification of the many considerations, responsibilities, personnel, and the transfer of knowledge. Medical device risk management helps gauge the possible hazards under both normal and fault conditions. It is understood that risk management transcends projects and even companies, thus it is crucial that critical information survive these many different transferences. Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device. During all stages of a product’s life cycle and supply chain risk management needs to focus on any new consideration must scrutinize the potential risk or harm to the health of people, damage to property, or to the environment throughout all phases of a project.
Why You Should Attend:
This webinar will leave with you a unique perspective and a very different approach which can be implemented for effective risk management. This will help if you are struggling to create, manage, and maintain all of the information found in the various Risk Management documents and files, all of which are often redundant, repetitive, and clustered together in an awkward manner. This session will help you simplify the task so that your design and manufacturing resources are spending too much time on documentation. This will ensure that enough time is spent on actual risk management and mitigation creating a win-win scenario.
- The 2019 approach to design control
- What do FDA and ISO say about it?
- How do you present it to management?
- What are the key steps in risk-based design control?
- How to implement risk-based design control in your company
- Bringing it all together – links to design and process
- Quality Assurance Departments
- Research and Development Departments
- Manufacturing Departments
- Engineering Departments
- Operations Departments
- Production Departments
- Design Assurance Departments
- Documentation Departments
- Senior Management