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Design Verification and Validation

This course strengthens the ability to connect design inputs with verification and validation evidence, reducing regulatory exposure during FDA and CE submissions. Participants will improve documentation practices, statistical evaluation, and traceability needed to support medical device design control activities. This Course is designed for professionals responsible for medical device design control, validation activities, quality documentation, and compliance.

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US $190 per learner

30-Days Unlimited Streaming Access

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REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Instructor : Alan M. Golden
  • Study time : 90 Minutes
  • Skill Level: Intermediate
  • Course ID: TF3595
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Verification and validation activities are essential for demonstrating that a medical device meets intended design requirements and user expectations. Incomplete design control practices can create significant regulatory concerns during FDA submissions and CE mark reviews, particularly when verification evidence, validation records, or traceability documentation are insufficient. Maintaining clear alignment between design inputs, testing activities, and documented outcomes remains critical throughout product development and quality assurance processes.


The session focuses on the practical application of design verification and validation within regulated medical device environments. The course addresses traceability from inputs through outputs, methods used for verification and validation including statistical approaches, and the preparation of protocols and supporting records. Attention is also given to handling discrepancies, documenting deviations, and developing trace matrices necessary for maintaining complete and inspection-ready design control documentation.

  • Strengthen Design Traceability and Validation Records:

    Medical device organizations must maintain clear evidence linking design inputs to verification and validation outcomes. This course develops practical understanding of trace matrices, protocol preparation, discrepancy handling, and supporting records needed for design control activities. Stronger documentation practices help reduce review deficiencies during FDA inspections and CE mark submission assessments.

  • Apply Verification and Validation Methods with Greater Consistency:

    Verification and validation decisions require documented justification supported by appropriate testing and statistical evaluation. This course clarifies methods used to confirm design requirements and user needs while improving consistency across development activities. Better alignment between validation evidence and documented inputs can reduce operational rework and regulatory questions during product review.

Key Areas Covered

  • Design control flow and placement of verification and validation activities within medical device development
  • Traceability from design inputs through verification and validation outputs
  • Verification and validation methods used to evaluate design inputs
  • Statistical techniques supporting validation activities and documented evidence generation
  • Development of protocols, records, and supporting validation documentation
  • Management of discrepancies and deviations during verification and validation activities
  • Preparation and use of trace matrices linking inputs and outputs
  • Regulatory considerations affecting FDA approval and CE mark submissions for medical devices

Who Must Attend

  • QA/QC Departments
  • Regulatory Affairs Teams
  • Research & Development Professionals
  • Manufacturing, Engineering & Operations
  • Production & Product Support Personnel
  • Medical Device Design, Development & Marketing Professionals

Quality training, expert insights, and answers that matter. Know your Expert

ALAN M. GOLDEN

Alan M. Golden brings extensive experience in medical device research, quality assurance, and regulated product development. During his career at Abbott Laboratories, he worked extensively with design control, validation, change control, CAPA, and risk management activities supporting both new and on-market products. His background includes quality assurance oversight for diagnostics and molecular divisions, along with global training experience focused on verification, validation, statistical applications, and regulated quality system practices.

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Ready to Strengthen Your Team? Let’s Build Your Training Plan.

Whether you’re looking for a single onsite workshop or a multi-team training series, we’ll help you design a program that fits your goals, timelines, and operational reality.

Your team deserves the clarity.
Your organization deserves the confidence.

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Our students love us ❤️

“Team appreciated the clarity. Especially on a few areas we were unsure about.”

Vice President, Quality Assurance

“Practical side was covered well. Not just theory.”


Engineer, Validation

“Content was organised. That made it easier to go back and review internally.”

Lab Manager, Quality Control

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