www.prorelixresearch.com PMS Process and Risk Management Plan: what is it?
The PMS process is focused on the collection and analysis of the data that comes from the various sources and is carried out according to a PMS plan to be established for each MD in order to: www.prorelixresearch.com
PMS Plan For Each MD
Update the design and manufacturing information, the instructions for use and the labelling;
Update the benefit-risk determination and improve the risk management;
Update the clinical evaluation;
Update the summary of safety and clinical performance;
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Identify the needs for preventive, corrective or field safety corrective action;
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Identify options to improve the usability, performance and safety of the device; Contribute to the post-market surveillance of other devices; Detection and reporting of trends. Risk management requirements for postmarket surveillance for medical devices.
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With PMS becoming a duty for medical device manufacturers, the effective risk management system becomes a priority as well as one of the three basic elements that ensure compliance and safety, alongside with PMS and clinical evaluation
Plan
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Risk Management
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According to the MDR, manufacturers are expected to provide evidence of a risk management plan created for the whole lifecycle of products. Such plans should be used for tracking and reducing any potential hazards and ensuring the safety of the devices.
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