2-day In-person Seminar on "Applying ISO14971 and IEC62304 - A guide to practical Risk Management" at Philadelphia

Top Quote GlobalCompliancePanel will hold a RAPS approved two-day, in-person seminar in Philadelphia on the topic, "Applying ISO 14971 and IEC 62304 - A guide to practical Risk Management" on November 7 and 8, 2013 (Thursday and Friday). Markus Weber, Principal Consultant with System Safety, Inc., will be the speaker at this two-day session. End Quote
  • Philadelphia, PA-NJ (1888PressRelease) September 26, 2013 - What the seminar is about:
    This seminar relates to issues to consider for complying with ISO 14971, IEC 62304 and IEC 60601-1:2005, the global standards governing regulations and guidelines for software in medical devices. It particularly focuses on the cross-standard and practical means to integrate activities to cover these requirements documents. Since it is software that is the engine of a medical device; its regulation is necessary to enable it to perform its intended purposes, and this seminar will be about how to help organizations do this.

    The ISO 14971
    ISO 14971 is the global regulatory compliance standard aimed at ensuring the medical safety of a medical device. The foundational notion on which this standard is built is that medical device manufacturers have to take measures to anticipate and eliminate, or at least lessen risks to the best extent that they possibly can. ISO 14971contains the necessary processes by which these are to be done.

    The IEC 62304
    The IEC 62304 complements ISO 14971. It is the global standard for the development of medical software, as well as software within medical devices. This standard relates to medical device software and their software lifecycle processes.

    For IEC 62304, the software-related issues that form this standard's bases are software specification, architectures and the resulting design documentation. Naturally, the test of successful compliance of a medical device company with all the regulatory requirements is in how effectively it implements these standards.

    The IEC 60601-1:2005
    This seminar will also cover IEC 60601-1:2005, the standard which relates to risk assessment of several aspects of medical devices. The current version of this standard, arrived at in 2005 is its third.

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