Build processes that make conforming product every time, and prove it.
Three courses in the order manufacturing work happens: a Process FMEA that finds where the process can fail, safety risk management that ties those failures to patient harm, and process validation that proves the process is in control.
Training a team or paying by purchase order? Email us
3 courses · $3,500 instead of $4,500 · save $1,000
- 01Process FMEA (PFMEA)$1,500
- 02Safety Risk Management (SRM)$1,500
- 03Manufacturing Process Validation (MPV)$1,500
3 courses, in the order the work happens
Build processes that make conforming product every time, and prove it.
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Step 1
Process FMEA (PFMEA)
Bottom-up process failure analysis to raise yields, cut scrap and protect the design intent.
$1,500 aloneCourse details → -
Step 2
Safety Risk Management (SRM)
Risk acceptability, benefit-risk evaluation and a risk management file that stands up in review.
$1,500 aloneCourse details → -
Step 3
Manufacturing Process Validation (MPV)
A three-stage validation method with statistical tools and risk-based sample sizes.
$1,500 aloneCourse details →
Process FMEA first
The PFMEA shows where the process can fail and which controls matter, which tells you what to validate and how hard to look.
Then risk, then validation
Safety Risk Management connects process failures to patient harm under ISO 14971. Process Validation then proves, with statistics, that the process delivers conforming product.
After the path, you will be able to
Find process failures before they reach the line
Analyze the process step by step and put controls where they protect yield and the design intent.
Connect the process to patient safety
Trace process failure modes to hazards and harms, so risk controls are prioritized by what matters to patients.
Validate with a plan that holds up
Run installation, operational and performance qualification with risk-based sample sizes and clear acceptance criteria.
Show the process is in control
Use DoE, capability and measurement system analysis to prove the process makes conforming product every time.
Built by practitioners, with support when you need it
- Self-pacedWork through each course on your own schedule.
- Quizzes and a final examIn every course, to confirm you have it before moving on.
- Live expert supportAsk DQS about the material or your own device.
- Completion certificatesCourse, date and hours for your training records.
"Great material. Best I've ever seen in the industry."Mike Z.Senior Management Consultant
One method, across every engineer on the team.
When the whole team takes the same path, design files look the same, reviews go faster and new hires get productive without reinventing the format.
- Completion certificates for your training recordsCourse, date and hours, ready for ISO 13485 and QMSR competency evidence.
- Your examples, for larger teamsCourse examples and language can be adapted to your products.
- Multiple languages, coming soonThe library will be offered in more languages, so teams in different countries can train on the same method.
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 design control, risk management, FMEA and validation 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
Do I have to take the courses in order?
Can I buy the courses one at a time instead?
I already own one of these courses. Can I still get the path?
How do I get support if I get stuck?
Will I get a certificate?
Can my whole team take the path?
Manufacturing QA/QC Leader: the whole path, one price.
Build processes that make conforming product every time, and prove it.
$3,500 for 3 courses · save $1,000 · self-paced
Training a team or paying by purchase order? Email us