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Medical Device Industry - ISO 14971 - Application of Risk Management

The FDA and ISO 14971:2007 both acknowledge that the use of medical device technology entails some level of risk. The goal of risk management is to reduce product risk and to identify and understand the level of remaining risk and the impact that has on the users safety and the effectiveness of the product. PTC Integrity provides a configurable framework to apply the risk management practices of ISO 14971:2007 which allows organizations to improve the safety and effectiveness of their devices and enables them to demonstrate regulatory compliance. The benefits of using PTC Integrity for risk management of medical devices include:

  • Compliance with ISO 14971:2007 - The PTC Integrity solution for Medical Device companies provides a configurable Risk Management platform that leverages ISO 14971 risk management methodologies through the implementation of Hazard and Risk Analysis documentation, coupled with risk management and risk control processes that can be traced to product design as well as verification and validation records.
  • Automation of Complex Reports - ISO 14971:2007 and the regulatory requirements based upon this standard have specific reporting requirements, including the generation of a Risk Management File which details the risk analysis, risk evaluation, the implementation and verification of the risk control measures; and the assessment of the acceptability of any residual risk(s). PTC Integrity automates the generation of this report through built in traceability reports, allowing companies to easily export all of the risk documentation and any traced artifacts and verification results.

Risk And Requirement Traceability in Integrity

  • Configurable Risk Metrics and Policies – Organizations can tailor the PTC Integrity solution and refine the terminology to suit their needs. For example the values for Severity and Occurrence on a Risk may have their definitions modified to be quantitative rather than qualitative. The computations used to determine Risk Level (Acceptable, Unacceptable, Investigate) may also be tailored for the organization on a per project basis to allow the solution to be applicable to a variety of devices with distinct intended uses. Support is also provided for RPN calculations of Risk.
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  • Risk Coverage Charting and Reporting – Through real-time charting and reporting, PTC Integrity enables engineers to at a glance determine coverage across each of the risk domains. This includes the ability to identify Hazards that have no corresponding Risks, Risks that have no corresponding Mitigation or Control Measure, as well as Risk Control Measures which have not been verified.

 

Medical Device Risk Management Dashboard

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Reducing Manual Effort for Risk Management Compliance