ISO 14971 compliance is critical for avoiding the hazards associated with medical devices, including in vitro medical devices. ISO 14971 specifies the process for evaluating and controlling risks, and monitoring the success of the controls.
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Many manufacturers of medical devices have questions about ISO 14971 compliance--questions such as those listed below:
ISO 14971 compliance helps medical device manufacturers introduce safe medical devices into the marketplace by evaluating and controlling the risks associated with a medical device, and by evaluating a device's interactions with other devices.
The recently revised standards for ISO 14971 compliance (ISO 14971 2007) provide questions medical device manufacturers can use to identify medical device characteristics that could have an impact on safety.
Among other things, the revisions to ISO 14971 compliance provide examples of hazards, foreseeable sequences of events, and hazardous situations. This will undoubtedly entail stricter standards and make it more important than ever for manufacturers of medical devices to ensure that their methods for ISO 14971 compliance are up to the task of assuring compliance.
Because everything to achieve ISO 14971 Compliance is connected with everything else, other ISO standards you may want to be familiar with (and that MasterControl can help with) include: ISO 9000 2000, ISO 9001 2000 (these are general quality management standards); ISO 14000 (environmental management standards in production environments), and ISO 13485 (medical device quality management requirements for regulatory purposes).
To learn more about MasterControl and how MasterControl solutions can assure ISO 14971 compliance, please feel free to contact a MasterControl representative.