Design Validation Awareness for Medical Devices
Prove it works for users. Ask the right questions.
A short, self-paced course for the people who plan, review and approve Design Validation work. Learn what ISO 13485 clause 7.3.7 and the FDA QMSR require, the six types of Design Validation, and what convincing evidence looks like, without having to run the studies yourself.
Training a team or paying by purchase order? Email us
A meal bolus, quickly and confidently, from my phone
150 g of carbs entered instead of 15 g: severe hypoglycemia
Simulated Use with summative Human Factors, on production-equivalent units
45+ real users, a night-time alarm after a gap from training, every use error root-caused
By the end of the course you can read a validation plan like this and spot where it falls short.
For everyone who relies on Design Validation, not just the people who run the studies
If validation plans, protocols or reports land on your desk, this course gives you the vocabulary and the questions.
Managers and executives
Know what convincing validation evidence looks like before you sign off on it.
Project Managers and sponsors
Plan studies, test units and sample sizes before they hit the schedule.
Cross-functional team members
R&D, marketing, clinical, manufacturing and operations: contribute with confidence.
Quality and regulatory
See how clause 7.3.7, the QMSR, ISO 14971 and IEC 62366-1 fit together.
New hires
Get up to speed on how your company proves its devices meet User Needs.
Suppliers
Understand the validation evidence your customer needs from you.
Four things you’ll take into your next design review
Know what the rules require
What Design Validation is, why it pays off, and what ISO 13485 clause 7.3.7, the QMSR and the EU MDR expect.
Tell the activities apart
Design Verification, Design Validation and Process Validation, and the six types of Design Validation.
Follow one User Need
Trace the SmartPANC meal bolus through risk, critical tasks and Simulated Use to the validation report.
Judge plans and reports
Recognize realistic studies, sound sample sizes, convincing conclusions, and the mistakes FDA cites.
Eight short modules, one worked example
SmartPANC, an artificial pancreas system, carries the course from start to finish. A short check closes each module.
Orientation
Where Design Validation fits in the regulations, and the SmartPANC example we’ll follow.
What Design Validation is
The definition, clause 7.3.7, the QMSR and EU MDR, the payoff, and the mistakes FDA cites.
Verification, validation and Process Validation
Three activities that are often confused, and where each one happens.
The six types
Bench, Simulated Use, Human Factors, labeling, clinical and software, built in layers.
User Needs, inputs and outputs
Good User Needs, Essential Design Outputs, and tracing every need to its evidence.
Risk and usability
Hazard to harm, risk controls, use errors, critical tasks and what FDA expects from Human Factors validation.
Simulated Use, clinical and sample size
Realistic testing, learning loss, clinical investigations and how many participants is enough.
Plans, reports and the top mistakes
What a validation plan contains, conclusions that convince, and a 15-question final check.
Start here, or go straight to running Design Validation
Not sure which one you need? Awareness is for people who read and review validation work. The full course is for the people who plan, run and document it.
Design Validation Awareness for Medical Devices
- Read and question a validation plan and report
- Understand the six types and when each fits
- See how clause 7.3.7 connects to the QMSR, ISO 14971 and IEC 62366-1
- Certificate of completion
$249
Enroll nowMedical Device Design Validation
- Write the validation plan with a work instruction and templates
- Plan bench, Simulated Use, Human Factors and clinical studies
- Size studies with statistical methods
- Full $249 credit if you upgrade within 30 days
$1,500 before your credit
See the full course
Dr. John Salvato
Founder and President, Design Quality Services
More than 30 years in medical device and automotive quality and regulatory work. John has built and defended design control and risk management programs for device makers around the world.
Top Medical Device Consulting 2026, MedTech Business ReviewBefore you enroll
Do I need any validation experience?
How long does it take?
How does the upgrade credit work?
Do I get a certificate?
Can I enroll my whole team?
Walk into your next design review knowing what to ask.
Two and a half hours, one worked example, and a certificate at the end.
Enroll for $249Ready to plan and run Design Validation yourself instead? See the full course
Training a team or paying by purchase order? Email us