Medical Devices Risk.
Information & Training. | Medical Devices
Medical Device “Design” Risk Management.From initial concept, through prototype, investigational device stage and final release to manufacture, the potential risk to patients, medical staff, organizational employees and the wider community must be continually assessed. The risk needs to be related to the potential benefit associated with the device. There will be a need for regular planned design reviews, where competent individuals, representing all potentially affected stakeholders are represented. The design reviews must include fact based mechanisms for relating the potential risks which may arise during the device development in addition to the potential end use of the device.
Medical Device “Manufacturing” Risk Management.In the manufacturing process, the potential risks will have already been identified, documented and assessed, based on hand-over documentation from the development process. However, new risks can and will arise based on methods of processing applied, the introduction of new technology, materials used, packaging methods, etc.. Therefore, there will be a continual need to review and re-assess all potential risks. In the manufacturing stage, the focus on device risk management can change based on the different “sets of eyes” from those in the design stage. However, risk assessments performed during the manufacturing stage will build and add to the assessments performed in the design stage.
Medical Device “Use” Risk Management.As the medical device is applied in patient use settings, further risks may be identified. Risks may also arise based on a performance of the device which varies from expected. These risks may be minor and easily addressed or could range to major, if unforeseen patient reactions arise.
At all stages a comprehensive, systematic, fact based risk management process must be in-place. The individuals involved in contributing to the risk process, must be competent in the specific areas they are representing (e.g. engineering, IT, clinical, etc.). All key relevant disciplines need to input into the risk process. The risk assumptions made during the risk process must be challenged, therefore, individuals appointed to input into the risk management process will need leadership, communication and strong personality skills.
Analytical Tools and Techniques for Medical Device Risk Management.The Risk Management process will need to be fact based and will require analytical tools and techniques to be applied. There are a range of such methodologies, such as Cause and Effect, 5 Why’s Analysis, HAZOP, Fault Tree Analysis, Scatter Diagrams, Run Charts, Flow Diagrams, …etc., etc…
There will be a need to develop a Risk Management Plan, which will define the approach to the risk management process, how risk will be monitored and rated, how risk will be communicated, the attitude of the organization towards the levels of risk identified.
Where risks are identified that exceed levels deemed acceptable, then risk reduction will need to be performed. This usually takes the form of product or process redesign, implementation of safe-guards, or via communication of potential risks associated with the use of the medical device.
Risk Monitoring.Throughout the design, manufacture and continued use of the medical device, the risk assumptions, risk levels and risk controls in place will need to be continually monitored. The accuracy of the risk management process should be enhanced by performance feedback, also experience from similar or equivalent products in use should also be reviewed and should input into the risk process.
Information & Training. Medical Device:
- Validation. Classification. Regulation. Requirements. Current best practices.
- FDA cGMP’s, EU MDR’s / MDD’s.
- Risk Identification. Documentation. DHR’s. DMR’s.
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Information & Training.
- Risk Identification. Risk Evaluation. Risk Mitigation. Risk Control. Etc..
- Risk Processes. Risk Planning. Risk Reporting.
- Requirements. Standards. Current best practices.
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