ISO 14971 Compliance


MasterControl Ensures that ISO 14971 Compliance is Accurately Implemented in an Enterprise.

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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ISO 14971 Compliance Questions Manufacturers Have

Many manufacturers of medical devices have questions about ISO 14971 compliance--questions such as those listed below:

  • ISOとは、また ISO認証 の利点とは?
  • What is ISO 14971 compliance?
  • リスクマネジメントは何を意味するのか?
  • ISO 13485 とISO 14971との連携は?
  • マスターコントロールがどのように医療機器メーカーのISO 14971要求事項へのコンプライアンスを支援するか?

How ISO 14971 Compliance Helps Medical Device Manufacturers

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.

ISO 14971コンプライアンスに向けて近年改訂された規格基準

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.

Other ISO Standards that May be Relevant to ISO 14971 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).

For More Information on ISO 14971 Compliance

To learn more about MasterControl and how MasterControl solutions can assure ISO 14971 compliance, please feel free to contact a MasterControl representative.