MEDDV 111 - Database Management for Medical Devices

1. Describe the role of the Database Manger in a medical device manufacturing environment. [COMMUNICATE]
2. Define relational database and relational database management systems and describe their advantages and disadvantages. [COMMUNICATE]
3. List alternatives to relational database management systems and describe their advantages and disadvantages. [REASON]
4. Compare and contrast Extensible Markup Language (XML) and Structured Query Language (SQL). [REASON]
5. List and describe the components of both product and software lifecycles. [COMMUNICATE]
6. Define compliance as it relates to data storage and management and list common compliance standards used in medical device manufacturing. [REASON]
7. Identify and explain each component of security as defined by the Food and Drug Administration (FDA). [COMMUNICATE]
8. List the different levels of security and give an example of a department and / or position within a medical device manufacturer that would have access at that level. [REASON]
9. Create a backup and archiving plan. [ACT]
10. Describe how the Health Insurance Portability and Accountability Act (HIPAA) impacts database management and liability for the IT department. [ACT]