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

This webinar on FDA's design control requirements will discuss how a requirements management approach consistent with the CMMi Requirements Management KPA, helps companies meet FDA's 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.

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

Instructor Profile:

Mercedes Massana, is the founder and CEO of MDM Engineering Consultants, a consulting firm that provides engineering and quality consulting services in the medical device, biotechnology, and pharmaceutical industries.

Note:

Use coupon code NB5SQH8N and get 10% off on registration.