DFMEA Awareness for Medical Devices
Read a DFMEA. Ask the right questions.
A short, self-paced course for the people who review, approve and work alongside Design FMEAs. Learn what each column means, how the ratings work and what gets fixed first, without having to become an FMEA facilitator.
Training a team or paying by purchase order? Email us
Keep the seal at ≥2.5 N/15 mm after aging
Seal delaminates after EtO sterilization
Sterile barrier lost; product unusable
Adhesive spec doesn’t cover EtO compatibility
By the end of the course you can read a line like this and spot when it’s weak.
For everyone who sits in the DFMEA review, not just the person who writes it
If DFMEAs land on your desk, cross your approvals or shape your decisions, this course gives you the vocabulary and the questions.
Managers and executives
Know what a good DFMEA looks like before you sign off on it.
Project Managers and sponsors
Understand why actions need owners, dates and proof.
Cross-functional team members
R&D, marketing, operations and purchasing: contribute with confidence.
Quality and regulatory
See how the DFMEA feeds ISO 14971 and V&V, and where it doesn’t.
New hires
Get up to speed on how your company analyzes design risk.
Suppliers
Understand what your customer’s DFMEA asks of your part.
Four things you’ll take into your next design review
Read any DFMEA line
Follow function, failure mode, effect and cause, and tell when two of them have been mixed up.
Understand the ratings
Know what Severity, Occurrence and Detection each rate, and why every rating needs evidence behind it.
Know what gets fixed first
Recognize RPN, Action Priority and the severity gate, and why a score alone is never enough.
See the bigger picture
How the DFMEA feeds design verification, the PFMEA and the ISO 14971 risk analysis, and keeps living after launch.
Eight short modules, one example all the way through
Every module follows the same sterile pouch, so each idea builds on the last. A short check closes each module.
Orientation
Where DFMEA fits in the regulatory landscape, and the pouch we’ll follow.
What a DFMEA is
The FMEA family, how it differs from other tools, and function versus harm.
Start with function
Verb + noun + specification, breaking the device down, and interfaces.
The failure chain
Mode, effect and cause: three different things, and how to keep them apart.
Rating it
Severity, Occurrence and Detection, and prevention versus detection controls.
What to fix first
RPN, Action Priority, the DQS severity gate and complete action plans.
The bigger system
Links to V&V, the PFMEA, ISO 14971 and post-market data.
Team and top 5 mistakes
Who belongs on the team, the mistakes to avoid, and a 15-question final check.
Start here, or go straight to building DFMEAs
Not sure which one you need? Awareness is for people who read and review DFMEAs. The full course is for the people who build them.
DFMEA Awareness for Medical Devices
- Read and question a DFMEA
- Understand ratings and priorities
- See how it connects to ISO 14971 and V&V
- Certificate of completion
$249
Enroll nowDFMEA for Medical Devices
- Build a DFMEA from function analysis to final ratings
- P-Diagrams, fault trees and prioritization methods in depth
- Write entries that hold up in an audit
- 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 FMEA and risk management programs for device makers around the world.
Top Medical Device Consulting 2026, MedTech Business ReviewBefore you enroll
Do I need any FMEA 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 DFMEA review knowing what to ask.
Two and a half hours, one worked example, and a certificate at the end.
Enroll for $249Ready to build DFMEAs instead? See the full course
Training a team or paying by purchase order? Email us