Medical Electronics Symposium Conference Proceedings


BEYOND ISO14971 TO BUSINESS RISK MANAGEMENT

Authors: Edwin Smith, III
Company: Hart InterCivic
Date Published: 4/25/2005   Conference: Medical Electronics Symposium


Abstract: Medical device Original Equipment Manufacturers (OEM) and Electronic Manufacturing Service (EMS) providers use risk management tools to mitigate critical impacts to medical device design, manufacture, and use. ISO 14971 provides a framework for the risk process. This ISO standard addresses the design and the product, with scant comments toward other areas of risk to the medical device design or manufacturing firm.

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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