Key Considerations in Verification & Validation of Medical Devices

Duration: 75 Minutes
This medical device verification and validation training will dissect some of the FDA 483 observations related to design verification and design validation, and provide key information on how they can be prevented.
Instructor: Mercedes Massana
Product ID: 501081
Objectives of the Presentation
  • What is Verification and Validation
  • What are the major differences between Verification and Validation
  • The relationship between software validation and design validation
  • How to avoid FDA 483s related to verification and validation
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, which helps companies meet Design Control requirements. The presentation will show how the Requirements Management Specific Goals satisfy Design Control requirements.

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
  • 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 can 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
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
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 thirty 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: Systems Engineering, 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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