DFMEAs that make devices better.
Learn to write failure modes, determine effects, identify causes, and estimate ratings that are measurable, traceable to verification and easy to defend when an auditor asks why.
Training a team or paying by purchase order? Email us
13 chapters · 2+ hrs video · IEC 60812 and AIAG/VDA aligned
Top Medical Device Consulting 2026 MEDTECH Business Review"An excellent, well written course." Mike Z., Senior Management Consultant
- Failure mode
- Seal fails
- Effect
- Patient infection
- Cause
- Spec error
- Control
- Visual inspection
- Ratings
- Failure mode
- Seal peel strength below specified minimum
- Effect
- Sterile barrier lost; product unusable (end effect, device function)
- Cause
- Seal width permits peel strength outside of the performance spec
- Control
- Seal strength test in design verification, linked to the V&V plan
- Ratings
- Hazard flag
- Yes · carried to the ISO 14971 analysis, where harm is evaluated
The DFMEA exists. It just isn't doing any work.
- It was built the week before launch, to tick a box in the procedure.
- The team spends hours arguing whether Occurrence is a 4 or a 5, and nobody can point to data.
- Failure modes say, "doesn't work." Causes say, "see drawing."
- A reviewer asks how the DFMEA shaped the design, and the team that created it looks sheepish.
That isn't a lack of effort. It's the lack of a method that holds together from function analysis to final ratings. This course teaches that method.
How does your last DFMEA hold up?
Answer for the most recent DFMEA your team finished. Your answers stay on this page and aren't sent anywhere.
- Did your team start this DFMEA before design freeze?
- Is each potential failure cause written as something you can control or evaluate?
- Are effects written as loss of device function, with harm left to the ISO 14971 analysis and flagged for transfer?
- Can you point to data or a test behind every Occurrence and Detection rating?
- Did you choose your prioritization method on purpose, with a severity gate?
After the course, your team will be able to
Write entries a reviewer can test and trace
Structured, measurable language that points to a real characteristic, so every line connects to something you can verify.
Defend every rating
Assign S, O and D from objective data and defined criteria. The next time someone asks "why a 5?", you have the answer.
Pick the right prioritization method
Know when RPN misleads, when Action Priority fits, and how to spend design effort on the risks that matter most.
Make one analysis feed the whole file
Link DFMEA outputs to design verification and validation, safety risk management and post-market surveillance, and flag which failure modes go to the safety risk analysis, so the story stays consistent.
Built for the people who own, write and review DFMEAs
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 builds or contributes to DFMEAs.
- You work in quality or design assurance and review DFMEAs before they go into the design history file.
- You come from QA/RA and need to understand the engineering side well enough to challenge it.
- You lead a team and want one consistent method across every product line.
- You are moving from automotive and want to see how FMEA works under medical device regulations.
It is probably not for you if
- You want a one-hour overview of FMEA vocabulary.
- You are looking for a worksheet template to fill in without changing how your team works.
Four stages, from first principles to a finished DFMEA
Short lessons you can fit between meetings, with a quiz at each stage to confirm you have it before moving on.
Foundations
Where FMEA came from, what a good one looks like on a real device, and the tool set you will use.
Chapters 1–3Building the analysis
Tie the DFMEA to design verification and validation, then write failure modes, effects and causes that hold up.
Chapters 4–7Rating the risk
Severity, Occurrence and Detection, each rated from criteria and evidence instead of opinion.
Chapters 8–10Prioritize and apply
Choose a prioritization method, work through a complete sterile pouch DFMEA, and take away best practices.
Chapters 11–13- 2+ hrs of video in 75 short videos and 158 lessons
- 190 quiz and final exam questions to check understanding
- Worked DFMEAs on an example device and a sterile pouch
- Downloadable course materials
Not sure yet? Start Chapter 1 free. You get access inside the course as a student and can work through the whole chapter before you decide.
Chapters marked "Your gap" match the answers you gave in the DFMEA check.
- FMEA BackgroundYour gap
- DFMEA ExamplesYour gap
- FMEA Tool IntroductionYour gap
- DFMEA and Design Verification & ValidationYour gap
- Failure ModesYour gap
- Failure EffectsYour gap
- Failure CausesYour gap
- Failure Effect SeverityYour gap
- Failure Cause OccurrenceYour gap
- Failure Cause DetectionYour gap
- Risk Prioritization MethodsYour gap
- DFMEA Analysis: Sterile Pouch ExampleYour gap
- DFMEA Best Practices and SummaryYour gap
DFMEA works best as a team method. Train the team on one.
When every engineer learns the same approach, DFMEAs look the same across products, reviews go faster, and new hires get up to speed without reinventing the format.
- A shared vocabularyOne way to write failure modes and justify ratings, across every product line.
- Pairs with the rest of the libraryProcess FMEA, Safety Risk Management and Design Validation 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 rebuilt design control, risk management and FMEA 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?
My background is QA/RA, not design engineering. Will I keep up?
Does it cover AIAG-VDA Action Priority, or only RPN?
How does DFMEA relate to ISO 14971?
Make your next DFMEA the one that changes the design.
Learn a 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