Key Considerations in Verification & Validation of Medical Devices

Why Should You Attend:

Verification and Validation are required as part of 21 CFR § 820.30. A review of recent FDA 483 observations indicates that a number of observations documented deficiencies in design verification and design validation. By learning from other firm’s mistakes and instituting a sound verification & validation strategy, along with proper verification and validation planning, these types of observations can be prevented.

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:

We will cover key considerations and best practices when performing design verification and design validation of medical devices.It is intended to give the attendees key knowledge in areas that are repeatedly cited in FDA 483s. The presentation will cover verification and validation related observations including,

• Failure to conduct design validation using production units or their equivalents
• Failure of the verification testing to confirm that the design outputs meet the design input requirements
• Failure to ensure that design testing is conducted under actual or simulated use conditions
• Failure to maintain written design testing results

Areas Covered in the Webinar:

• How to properly plan Verification and Validation activities.
• Verification & Validation testing throughout the product life cycle.
• How to determine sample sizes needed for testing.
• What is appropriate objective evidence.
• How to perform regression analysis.
• What is meant by Production Equivalence.
• How do we validate test methods.
• Special considerations for software based products.

Who Will Benefit:

This webinar will provide valuable assistance to medical device companies in performing verification and validation testing throughout the product lifecycle. The employees who will benefit include:

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

Mercedes Massana
Founder & CEO, MDM Engineering Consultants

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.

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