Ensure Compliance to FDA’s Design Control Requirements by using Requirements Management Techniques

This Webinar will discuss how a requirement management approach consistent with the CMMi Requirements Management KPA, helps companies meet Design Control requirements

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.

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.

Who Will Benefit:

This webinar will provide valuable assistance to medical device companies in managing requirements throughout the product lifecycle to avoid pitfalls that tend to derail projects and result in FDA observations. The employees who will benefit include:

• Systems engineers responsible for developing requirements
• Software developers
• Test Engineers
• Quality System auditors
• Engineering managers and personnel