MEDDV 111 - Database Management for Medical Devices

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