Review design and risk files with the confidence to challenge them.
Three courses that give quality and design assurance the same depth as the engineers whose work they review: design and development, safety risk management under ISO 14971, and design validation.
Training a team or paying by purchase order? Email us
3 courses · $3,000 instead of $4,000 · save $1,000
- 01Design & Development$1,000
- 02Safety Risk Management (SRM)$1,500
- 03Design Validation$1,500
3 courses, in the order the work happens
Review design files and risk files with the confidence to challenge them.
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Step 1
Design & Development
One framework from voice of the customer to design transfer, with your design and development file built as you go.
$1,000 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
Design Validation
Six validation types, from analytical to clinical, planned to show the device meets user needs the first time.
$1,500 aloneCourse details →
Design & Development first
You can only challenge a design file if you know what a good one looks like. This course sets the standard for inputs, outputs, reviews and traceability.
Then risk, then validation
Safety Risk Management shows how hazards, risk controls and benefit-risk should flow through that file. Design Validation closes the loop by proving the device meets user needs.
After the path, you will be able to
Tell a robust design file from a thin one
Know what complete design inputs, outputs and traceability look like, and where reviewers find gaps.
Challenge a risk analysis on substance
Judge whether hazards, risk estimates and controls are defensible, not just whether the template is filled in.
Sign off with confidence
Evaluate overall residual risk and benefit-risk, and know when a risk management file is ready for review.
Ask the right validation questions
Check that the validation type, sample size and acceptance criteria actually prove the device meets user needs.
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?
Quality / Design Assurance Leader: the whole path, one price.
Review design files and risk files with the confidence to challenge them.
$3,000 for 3 courses · save $1,000 · self-paced
Training a team or paying by purchase order? Email us