Why Should You Attend:
With headlines reading "Device firm cited for faulty design input requirements, not validating device design." it is important to understand the FDA regulations related to design inputs and how they impact other design control elements. Requirements Management is a CMMi level 2 Key Process Area (KPA) which involves managing versions of requirements and the relationship between requirements and the project deliverables. Using this model as a best practice, can result in a more robust design control process and minimize FDA observations.
There is a wide variation of how the medical device industry manages requirements. This presentation will cover a requirements management approach consistent with the CMMi Requirements Management KPA, that helps companies meet Design Control requirements. The presentation will show how the Requirements Management Specific Goals satisfy Design Control requirements. Specific Goals to be reviewed are: Obtaining an Understanding of Requirements, Obtain Commitment to the Requirements, Manage Requirements Changes, Maintain Bidirectional Traceability of Requirements and identify Inconsistencies Between Project Work and Requirements.
Areas Covered in the Seminar:
- What is the connection between Requirements Management and Design Controls.
- How to handle Essential Requirements and Critical to Quality Requirements using your Requirements Management Process.
- How far to elaborate on requirements to ensure ease of development and testing.
- How to properly evaluate and accept requirements.
- How to perform bidirectional traceability of requirements.
- How to manage and control requirements changes.
- What requirements metrics should you gather.
- Using requirements attributes to facilitate managing your requirements.