Industries: Medical Device

Design Validation, Verification, and Risk Analysis for Medical Device Professionals

Course Director: Jim Rosa

Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

This course covers current FDA regulatory compliance with respect to developing medical devices. Focus will be placed on relevant aspects of FDA regulation to V&V and Risk Analysis and the FDA's supplemental guidelines. An ISO perspective is offered to compliment the FDA view.

Among the topics to be discussed are: Context of V&V and Risk Analysis within the overall quality system and regulation, V&V and Risk analysis procedures, V&V methodologies, V&V strategies, types of risk analysis, risk mitigation, and methods to determine probability and severity for Risk analysis.

Who Should Attend

This course will be most valuable to medical device industry engineers, engineering managers, regulatory affairs professionals, scientists, and quality engineers needing an understanding of Validation and Verification (V&V) per FDA's 21 CFR Part 820.30 (f, g), ISO 13485-2003, and Risk Analysis Techniques consistent with ISO 14971-2007, as well as EN ISO 14971-2012.

Personnel involved in product development, design, manufacturing, quality assurance, or regulatory affairs that do not have an in-depth knowledge of Design V&V, Risk Analysis, and its workings, will benefit from this course. Additionally, this program can be customized and delivered on-site for more experienced personnel (including middle and upper management) to update and broaden their knowledge in these subjects.

First Day

Context for Validation, Verification, and Risk Analysis within the Medical Device Project

  • Verification vs. Validation vs. Qualification
  • Where do Validation, Verification, and Risk Analysis come from?
  • FDA vs. ISO perspective
  • FDA regulations (law)
  • Related FDA guidelines
  • Context from ISO 13485:2003 standard
  • Context from ISO 14971:2007 and EN ISO 14971:2012 standards
  • Context from ISO 62304 standard
  • Context from ISO 62366 standard
  • Related aspects of FDA regulations/ISO standard
    • Planning
    • Design Input, Output
    • Reviews
    • Record keeping
    • Documentation standards

Context within Procedure Based Quality System

  • Purpose of quality system
  • Need for Validation, Verification, and Risk Analysis Procedures
  • Typical content for
    • Validation and Verification procedure
    • Risk Analysis Procedure

Development of Validation and Verification Plan

  • Purpose of the Master Validation and Verification (MV&V) Plan
  • Typical Contents of MV&V Plan
  • Some typical medical device technologies
  • V&V planning methodologies needed for various medical device technologies

Use of Validation and Verification Protocols

  • Purpose of the Validation and Verification protocol template
  • Sections of V&V protocol template
  • Traceability considerations
  • Style for test input, expected results, actual result, signatures
  • How to determine expected results

Validation Methodologies

  • What is the definition of Validation
  • What are the different types of Validation
  • What is difference between Design Validation and Process Validation?
  • Where does IQ/OQ/PQ fit
  • Using Process Validation model for SW development tools

Second Day

Verification and Verification Strategies

  • Start with requirement specifications as basis of what to apply V&V towards
  • Determining test classes and test types
  • Developing a matrix to provide overview – bring it back to V&V plan
  • Special Cases
    • Reliability assessment
    • Designed experiments
    • Usability / Human Factors Engineering techniques
    • Test method validations

Methodologies to Analyze Risk

  • Various tools and method that are used for purpose of risk determination
  • Common design risk evaluation tools/methods
    • FMEA/FMECAs (Failure Modes and Effects Analysis/ Failure Modes and Effects and Criticality Analysis
    • FTA (Fault Tree Analysis)
    • Summary Risk Analysis
    • Risk/Safety Assurance Cases
  • Other risk evaluation methods
    • Process FMEAs
    • PHA (Preliminary Hazard Analysis)
    • HACCP (Hazard Analysis and Critical Control Points)
    • HAZOP (Hazard and Operability Analysis)

Creation of Summary Risk Analysis

  • Defining Hazards
  • Typical Hazards for various types of medical devices
  • Using a Risk Analysis template from Global Harmonization Task Force
  • Severity Determination
  • Probability Determination
  • Risk Determination
  • Risk Mitigation
  • Residual Risk


  • FDA Guidance
  • ISO standards
  • ISO guidance
  • GHTF

Learning Objectives

Upon completion of this course, attendees will have an understanding of the framework for Design V&V, Risk Analysis and recommendations to effectively meet the regulatory requirements relating to these. Emphasis will be placed not only on regulatory aspects, but on effective strategy, which is very important to avoid spending unnecessary time and money on ineffective techniques while ensuring that the requirements for medical products are met successfully.

The first day will cover the general context for V&V and Risk Analysis in relation to quality systems, standards, and procedures. The course will then focus on implementation aspects of key parts of V&V which will continue into the second day. Attendees will participate in several exercises designed to reinforce key concepts from the presentation. Participants will receive extensive course notes that can be used as reference material once the course is completed.


"The instructor had good depth and breadth of knowledge and presented it very well. A great introduction to the course material." Dan C., V & V Research Engineer, Kardium
"The course was fantastic. It was the best Medical Device Course I have attended." David H., Clinical Trials Coordinator, Cook Biotech
"The course was very informative. The course director was well informed and conveyed a wealth of experience in the practical application of course material." Alastair R., Doctor, D3 Technologies
"This course was very beneficial and went into more detail that I expected. The real life examples were great. The instructor did a nice job of keeping the class engaged and attentive. This was a useful course and I would recommend it." Jennie R., Clinical Research Associate, Ocular Therapeutics
"This course director has an extensive fund of knowledge and experience in regulatory affairs, clinical research and compliance, which he communicates very effectively to course attendees. He has enabled me and inspired me to pay greater attention to detail in the course of my clinical research activities as a multi-center trial P.I. than ever before. Thank you!" Dr. Alexander S., Colonel, US Army
"The Course Director, Byron Larson, was very engaging. His course exercises really helped implement the course material in a hands on approach." Nicole G., Biochemist, Siemens Healthcare Diagnostics
"Presentation highly organized and timed. Highly recommended!" Joseph W., Manufacturing Engineer, Covidien
"The instructor did an excellent demonstration of validation versus verification. The instructor took a myriad of questions from attendees with significantly different knowledge bases and answered them thoughtfully and with excellent real life examples." Anthony G., Validation Manager, BioMimetic
"Great course filled with so much useable information." Lynn C., QA Manager, Stemcell Technologies
"The course director showed his breadth of knowledge by providing examples and background on demand on all the topics we covered. He specifically helped me with practical guidelines for my 'task at hand'. This was a valuable class!" Richard P., Software Developer

Frequently Asked Questions

Is the course different than the Design Control Course?

Yes. The Design Validation, Verification, and Risk Analysis course provides a deeper, narrower, and more strategic look at the topics of Validation, Verification, and Risk Analysis as compared to the Design Control course. The Design Control course covers greater breadth and a more comprehensive overall view of Design Controls. The two courses are intended to be complimentary.

Does the course also cover ISO 13485-2003 or ISO 14971:2007 / EN ISO 14971-2012?

The course does discuss the relationship between relevant parts of the ISO 13485-2003 and FDA's 21 cfr part 820 regulation. After a comparison is established, the course materials follow FDA's 21 cfr part 820.30 references. Since the ISO 13485:2007 is not a free standard, it is not possible to distribute it with the course material.

The course also applies concepts consistent with ISO 14971:2007 as well as EN ISO 14971:2012. Since the ISO 14971:2007 and EN ISO 14971:2012 standards are not free, it is not possible to distribute it with the course material.

What materials come with the course?

A course notebook is provided that contains the slides that are presented, publicly available reference materials from FDA and other entities, class exercises, and example documents and procedures.

Are there particular types of medical devices emphasized?

No. A wide variety of medical device types are affected by the regulation, thus a broad view is presented.

Are any other topics covered outside of Design Validation, Verification, and Risk Analysis?

To the extent that other Design Control topics touch Design, Validation, Verification, and Risk Analysis, they will be discussed. Process Validation is discussed to the extent it can be contrasted with Design Validation.