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

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 Webinar:

• 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.

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. Mercedes has over twenty-five years of experience in the Medical Device industry. Extensive experience in developing processes within the constraints of FDA/lSO Quality Systems. She has been responsible for establishing processes and leading groups of engineering in the following disciplines: Risk Management, Requirements Management, Verification and Validation, Process Improvements, Project Management, Software Systems Validation, Process Validation. Mercedes is an ASQ certified Biomedical Auditor (CBA), Software Quality Engineer (CSQE), Quality Manager (CQMa) and Quality Auditor (CQA). Mercedes is well versed in FDA and ISO regulations.