BE 3005 - Professional Topics in BME

• Identify what constitutes human subject research and describe the IRB approval process
• Identify ethical considerations for scenarios involving the medical device industry
• Identify relevant sources of standards and codes related to specific medical devices
• Identify ways to mitigate patient risk associated with medical devices
• Identify whether a device is an FDA medical device and its likely FDA classification
• Describe FDA Quality System Regulation design controls and identify when they apply to the medical device design and manufacturing processes
• Identify methods to ensure quality in the manufacture of medical devices
• Identify salient considerations of the various career options in BME
• Use formal methodology to identify design requirements
• Describe the general options for protecting the intellectual property of medical device designs
• Articulate different viewpoints of a current controversial issue, including how each impacts marketing and accessibility of medical devices.

• None

• Introduction to FDA regulation of the medical device industry and device classification
• Codes and standards (including JCAHO, NFPA, NEC, AAMI, ANSI, IEC 60601)
• Introduction to intellectual property protection
• Using library resources to research literature, standards and patents and navigate the FDA website
• FDA QSR design control requirements overview
• Identification of user requirements and design requirements for medical devices
• Hazard analysis and risk mitigation in device design
• Quality control processes for medical device manufacture
• Medical device and health care economics and market analysis
• Human subject research and the IRB process
• Human factors and medical error involving devices
• Career options in BME
• Fundamentals in clinical engineering/health care technology management
• Using career placement resources to find jobs and internships and apply for graduate school
• Ethics in the medical device industry
• Contemporary BME issues