Risk files that deliver more robust device designs and protect patients.
Build Risk Management Plans, Risk Analyses and Overall Residual Risk evaluations that follow ISO 14971 and stay current with post-market data, practiced step-by-step on a sample device.
Training a team or paying by purchase order? Email us
11 chapters · about 16–20 hours · built on ISO 14971
Top Medical Device Consulting 2026 MEDTECH Business ReviewWorked example: infant heel warmer plus sample device exercises with DQS answers
- Hazard
- Heat
- Harm
- Injury
- Control
- Warning in the IFU
- Evidence
- Hazard
- Thermal energy
- Situation
- Warmer surface exceeds the safe skin-contact limit while on the infant's heel
- Harm
- Burn to the skin
- Control
- Temperature limit by design, with an independent thermal cutoff
- Evidence
The Risk Management File exists. It just isn't managing risk.
- The risk file is written after design freeze, to satisfy the auditor.
- Hazards, Hazardous Situations and Harms are mixed together, so nothing traces.
- Risk controls default to "warning in the IFU," and nobody verifies they work.
- Complaint and post-market data never make it back into the Risk Management File.
That isn't a lack of effort. It's the lack of a process that connects hazards, controls, evidence and post-market data. This course teaches that process.
How does your Risk Management File hold up?
Answer for the most recent product whose risk file your team built or updated. Your answers stay on this page and aren't sent anywhere.
- Did risk management start before design freeze, with a Risk Management Plan that sets your acceptability criteria?
- Is each line written as a chain, from Hazard to Hazardous Situation to Harm?
- Do your Risk Control Measures (RCM) span all three levels: Safety by Design, Safety from Protection, and Safety from Information?
- Is each risk control verified for both implementation and effectiveness?
- Do complaint and post-market data flow back into the Risk Management File?
"Great material. Best I've ever seen in the industry."Mike Z.Senior Management Consultant
After the course, your team will be able to
Build the four core documents
Create and maintain the Risk Management Plan, Risk Analysis, Overall Residual Risk evaluation and Risk Management Review.
Trace every risk from Hazard to Harm
Use the Hazard-to-Harm chain and clear technical writing so every line is specific, traceable and defensible.
Control risk the right way
Apply the risk control hierarchy, verify implementation and effectiveness, and weigh residual risk against medical benefit.
Keep the file alive
Feed post-market data back into the file with trending and update triggers, link Critical Tasks to Human Factors, and meet auditor expectations.
Built for the people who own, build and defend the risk file
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 contributes hazards, analyses or risk controls.
- You own the Risk Management File for one or more products.
- You work in quality or regulatory and review risk files before audits and submissions.
- You need to connect Risk Management with Human Factors and post-market surveillance.
- You work on software or connected devices and need to see how related standards fit.
It is probably not for you if
- You want a one-hour overview of ISO 14971 vocabulary.
- You are looking for a risk file template without changing how your team manages risk.
Four stages, from Risk Management Plan to a living file
Hands-on work on a sample device and a full worked example, plus a quiz in every chapter.
Foundations and planning
Why risk management matters, key definitions, the four core documents, and the Risk Management Plan.
Chapters 1–2Analysis
Risk Analysis from Hazard to Harm, then a complete worked example on an infant heel warmer.
Chapters 3–4Evaluate and review
Overall Residual Risk, benefit-risk, and the Risk Management Review before release.
Chapters 5–6Sustain and connect
Post-market surveillance, Human Factors, technical writing and related standards, including software and security.
Chapters 7–11- 16–20 hrs of learning in 183 lessons
- 11 quizzes plus a final exam
- Sample device exercises in four chapters, with DQS answers
- Worked example on an infant heel warmer
Not sure yet? Start Chapter 1 free. You get access inside the course as a student, including the first sample device exercise and quiz, before you decide.
Chapters marked "Your gap" match the answers you gave in the risk file check.
- Introduction and FoundationsYour gap
- Risk Management PlanYour gap
- Risk AnalysisYour gap
- In-Class Example: Infant Heel WarmerYour gap
- Overall Residual RiskYour gap
- Risk Management ReviewYour gap
- Post-Market Surveillance and Risk ManagementYour gap
- Usability Engineering and Human FactorsYour gap
- Technical Writing for Risk ManagementYour gap
- Related StandardsYour gap
- Course ConclusionYour gap
Risk management is a team effort. Train the team on one process.
When design, quality and regulatory share the same approach, hazards are written the same way, controls are verified, and the file tells one consistent story to every auditor.
- A shared vocabularyOne way to write Hazards, Hazardous Situations, Harms and risk controls across every product.
- Pairs with the rest of the libraryDesign FMEA, Process FMEA, Usability Engineering and Cybersecurity Risk Management courses feed the same file.
- 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 and remediated risk management files 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 do FMEAs fit with ISO 14971?
Does it cover software, AI/ML and cybersecurity?
Will this help with audits?
Make your next risk file the one that holds up.
Learn a risk management process 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