Know you designed the right device for business success.
Write User Needs you can actually validate, choose the right type of Design Validation, and justify every sample size, practiced step-by-step on a sample device.
Training a team or paying by purchase order? Email us
12 chapters · about 16–20 hours · 8 hands-on exercises with templates
Top Medical Device Consulting 2026 MEDTECH Business Review"Very well done. I learned a lot!" Mike Z., Senior Management Consultant
- User Need
- Device is easy to use
- Method
- User survey
- Sample
- n = 10, same as last project
- Pass if
- User Need
- Caregiver primes and connects the set at home without help
- Method
- Simulated Use with representative caregivers
- Sample
- n = 29, justified at 95% confidence / 90% reliability, zero failures
- Pass if
The validation report exists. It just doesn't prove much.
- User Needs say "easy to use" or "safe," so there's nothing measurable to validate against.
- Design Validation and Design Verification blur together, and the user is never really in the room.
- Sample sizes are "what we did last time," with no confidence or reliability behind them.
- One big study at the end, so the first real failure shows up right before launch.
That isn't a lack of effort. It's the lack of a method that connects User Needs, risk, Design Outputs and evidence. This course teaches that method.
How does your Design Validation hold up?
Answer for the most recent device your team validated. Your answers stay on this page and aren't sent anywhere.
- Is each User Need written so you can tell whether it was met?
- Does your validation involve intended users or actual use conditions, kept separate from Design Verification?
- Do you validate in stages as the design matures, instead of one study at the end?
- Is every sample size justified with a stated confidence and reliability?
- Are your Essential Design Outputs identified from Risk Management and covered by validation?
After the course, your team will be able to
Write needs you can validate
Find and author well-crafted User Needs, then translate them into measurable Design Inputs that validation can actually test.
Validate in layers, not in one big study
Choose the right type of Design Validation for each need, so problems surface early instead of the week before launch.
Defend every sample size
Select sample sizes on sound engineering judgment and statistics, and explain the rationale when a reviewer asks.
Focus on what matters most
Link Risk Management to Design Outputs to identify Essential Design Outputs, and document it all in clear technical writing.
Built for the people who plan, run and defend Design Validation
See who it's for, and who it isn't
This course is for you if
- You are a design or R&D engineer who writes User Needs, Design Inputs or validation protocols.
- You work in quality or design assurance and review validation plans and reports.
- You are unsure where Design Verification ends and Design Validation begins.
- You need to justify sample sizes to auditors and reviewers, not just pick them.
- You lead a team and want one consistent validation approach across every product line.
It is probably not for you if
- You want a one-hour overview of Design Controls vocabulary.
- You are looking for a report template without changing how your team plans validation.
Four stages, from User Needs to objective evidence
Each stage includes hands-on exercises on an example device, plus quizzes to confirm you have it before moving on.
Foundations
What Design Validation is, how it differs from Design Verification and Process Validation, and the types you can use.
Chapters 1–3Needs, inputs and outputs
Develop User Needs with a journey map, translate them into Design Inputs, and define Design Outputs.
Chapters 4–6Risk and writing
Use Risk Management to find Essential Design Outputs, and write plans and reports that are clear and defensible.
Chapters 7–8Validate in layers
Usability, Simulated Use and clinical investigations, then a deep dive into Sample Size Selection.
Chapters 9–12- 16–20 hrs of learning in 231 lessons
- 19 quizzes plus a final exam
- 8 exercises on an example device, with DQS answer review
- Activity templates to use on the job
Not sure yet? Start Chapter 1 free. You get access inside the course as a student, including the Chapter 1 quiz, before you decide.
Chapters marked "Your gap" match the answers you gave in the validation check.
- Introduction to Design ValidationYour gap
- Key Distinctions in ValidationYour gap
- Types of Design ValidationYour gap
- User Needs DevelopmentYour gap
- Design InputYour gap
- Design OutputsYour gap
- Risk ManagementYour gap
- Technical WritingYour gap
- UsabilityYour gap
- Simulated UseYour gap
- Clinical TrialsYour gap
- Sample Size SelectionYour gap
Validation is a team effort. Train the team on one method.
When design, quality and regulatory share the same approach, User Needs get written to be validated, studies are sized correctly, and reports hold up in review.
- A shared vocabularyOne way to write User Needs, Design Inputs and acceptance criteria across every product line.
- Pairs with the rest of the libraryDesign Controls, Usability Engineering and Safety Risk Management courses build on the same foundation.
- Impact your business positivelyInvestment in professional development is not a 'nice-to-have'. It has real, tangible benefits.Get the white paper
Dr. John Salvato
John has spent more than 30 years in medical device and automotive quality and regulatory work. Since founding DQS in 2017 he has built design control, validation and risk management methods for device makers around the world, and defended that work with agencies and regulatory bodies.
"What we offer is capability-focused training. We understand the regulation, but we are also going to teach you how to implement it smartly."
Questions people ask
Can I try it before I buy?
How much time does it take?
How is Design Validation different from Design Verification?
Do I need a statistics background for the sample size chapter?
Does it cover Human Factors and clinical investigations?
Make your next Design Validation the one that holds up.
Learn a validation method your team can defend in every design review, audit and submission.
$1,500 · self-paced · start today
Training a team or paying by purchase order? Email us