Design and Development Awareness for Medical Devices
Trace the design. Ask the right questions.
A short, self-paced course for the people who review, approve and work alongside design controls. Learn what ISO 13485 clause 7.3 and the FDA QMSR require, how user needs become inputs, outputs and tests, and what verification and validation prove, without having to run the process yourself.
Training a team or paying by purchase order? Email us
A meal bolus, quickly and confidently, from my phone
Show the calculated dose and require confirmation
Confirm screen spec and carb-limit logic
Verified on the bench; validated with patients in simulated use
By the end of the course you can trace a line like this and spot where it breaks.
For everyone who works alongside design controls, not just the engineers who run them
If design plans, design reviews or traceability matrices land on your desk, this course gives you the vocabulary and the questions.
Managers and executives
Know what good design control looks like before you sign off on it.
Project Managers and sponsors
Plan reviews, verification, validation and transfer before they hit the schedule.
Cross-functional team members
R&D, marketing, clinical, manufacturing and operations: contribute with confidence.
Quality and regulatory
See how ISO 13485 clause 7.3, the QMSR and ISO 14971 fit together in the design file.
New hires
Get up to speed on how your company develops devices.
Suppliers
Understand the design inputs and changes your customer controls.
Four things you’ll take into your next design review
Know what the rules require
What design and development is, why it pays off, and the ten parts of ISO 13485 clause 7.3.
Follow the chain
Trace user needs to design inputs, outputs, verification, validation and transfer, first with soup, then with SmartPANC.
Judge plans, reviews and requirements
Recognize a useful design plan, a real design review, and user needs and inputs that can be tested.
Know what auditors look for
How risk feeds design, what verification and validation each prove, design changes, the design file, and the mistakes auditors find.
Eight short modules, two worked examples
A bowl of soup shows the whole chain in Module 2; SmartPANC, an artificial pancreas system, carries it from Module 3 on. A short check closes each module.
Orientation
Where design and development fits in the regulations, and the two examples we’ll follow.
What D&D is and why
The definition, the business case, clause 7.3, and phases and gates.
The big picture: soup
Needs, inputs, outputs, verification, validation, review and transfer on one simple product.
Planning and design reviews
What a design plan covers, who sits in a review, and how to tell if it is real.
User needs and design inputs
User and stakeholder needs, and design inputs that are measurable and solution-free.
Risk in design
Hazard to harm, the risk control priority order, and how FMEA and usability feed it.
Outputs, verification and validation
Essential design outputs, design freeze, and what verification and validation each prove.
Transfer, changes and the design file
Design transfer, change control, the DDF and MDF, and a 15-question final check.
Start here, or go straight to running design controls
Not sure which one you need? Awareness is for people who read and review design control work. The full course is for the people who plan, run and document it.
Design and Development Awareness for Medical Devices
- Read and question a design plan and traceability matrix
- Understand reviews, verification and validation
- See how clause 7.3 connects to the QMSR and ISO 14971
- Certificate of completion
$249
Enroll nowMedical Device Design and Development
- Build the design plan, traceability matrix and design file
- Run design reviews, verification, validation and transfer
- Templates and a procedure ready to use
- Full $249 credit if you upgrade within 30 days
$1,000 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 design control 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, two worked examples, and a certificate at the end.
Enroll for $249Ready to run design controls yourself instead? See the full course
Training a team or paying by purchase order? Email us