BEYOND ISO14971 TO BUSINESS RISK MANAGEMENTAuthors: Edwin Smith, III
Company: Hart InterCivic
Date Published: 4/25/2005 Conference: Medical Electronics Symposium
This paper describes how to take risk management beyond the product design and manufacturing to the supply chain, customer programs, information security. It provides a case study of how Hart InterCivic evolved risk beyond the product to a systemic and mature risk environment that encompasses the spectrum of its business activities.
The case study will include risk management in the outsourcing relationship, other partners in the supply chain, customer programs, and information security - areas neither required nor detailed in ISO 14971.
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