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- Medical Device Essentials and Cybersecurity Quality Audit Management
Medical Device Essentials and Cybersecurity Quality Audit Management
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The author has conducted many hundreds of independent audits in the oil and gas/offshore industries over the last 35 years for national and international companies worldwide to their various standards requirements. However, many existing clients (Oil and Gas as well as Healthcare enterprises, Hospitals) are now moving heavily towards cyber security based network vulnerability audits. To address the issue ISO 27001, ISO13485, ISO14971 and related standards were integrated with the existing ISO9001, 14001 and 18001 model to create a multipurpose audit plan. This short book, however, mainly focuses on the quality aspects of remote controlled electronic medical devices using BSC (Balance Score Card) system. It is the first of a series of books the author plans to publish in integrated cyber security audit management.
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