Risk Management for Medical Devices per ISO 14971
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 phases of a project, any new consideration must be held up against the scrutiny of potential risk and harm to the health of people, damage to property, or the environment during all stages of a product’s life cycle and supply chain.Risk management is a process that involves many considerations, responsibilities, personnel, and the transfer of knowledge. Given that it transcends projects and even companies, it is particularly critical that key pieces of information survive these many hand-offs.Areas Covered Risk management process as per ISO 14971 Management responsibilities Qualification of personnel Risk management planRisk management file Bringing it all together – links to design and processWho Should AttendManagers, Supervisors, Directors, and Vice-Presidents in the areas of:R&DManufacturing Engineering Design AssuranceQuality Assurance OperationsDocument ControlWhy Should You AttendIf you are constantly 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 webinar is something that will give you a different perspective and a very different approach that you can use.If your design and manufacturing resources are spending too much time on documentation and not enough time on actual risk management and mitigation, you as a manager need to be looking for ways to simplify the work at hand.
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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 phases of a project, any new consideration must be held up against the scrutiny of potential risk and harm to the health of people, damage to property, or the environment during all stages of a product’s life cycle and supply chain.
Risk management is a process that involves many considerations, responsibilities, personnel, and the transfer of knowledge. Given that it transcends projects and even companies, it is particularly critical that key pieces of information survive these many hand-offs.
Areas Covered
- Risk management process as per ISO 14971
- Management responsibilities
- Qualification of personnel
- Risk management plan
- Risk management file
- Bringing it all together – links to design and process
Who Should Attend
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
- R&D
- Manufacturing Engineering
- Design Assurance
- Quality Assurance
- Operations
- Document Control
Why Should You Attend
If you are constantly 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 webinar is something that will give you a different perspective and a very different approach that you can use.
If your design and manufacturing resources are spending too much time on documentation and not enough time on actual risk management and mitigation, you as a manager need to be looking for ways to simplify the work at hand.