Training path · 4 courses · Self-paced

Turn user needs into a design that holds up, from first input to validation.

Four courses in the order design work happens: design inputs and the design and development file, a Design FMEA that steers the design, usability engineering that keeps Use Errors out of the field, and validation that proves the device meets user needs.

Buy the path for $4,500 See the courses

Training a team or paying by purchase order? Email us

4 courses · $4,500 instead of $5,500 · save $1,000

Design Engineering LeaderYour path

01Design & Development$1,000
02Design FMEA (DFMEA)$1,500
03Usability Engineering & Human Factors (UEHF)$1,500
04Design Validation$1,500

Bought separately~~$5,500~~

Path price$4,500

You save$1,000

Courses in the order the work happens. Each one builds on the last.

The path

4 courses, in the order the work happens

Turn user needs into design inputs, a DFMEA, usability work and validation that hold up.

Step 1

Design & Development

One framework from voice of the customer to design transfer, with your design and development file built as you go.

QMSR · ISO 13485 7.3 · 14 chapters · about 16–20 hours

$1,000 aloneCourse details →
Step 2

Design FMEA (DFMEA)

Failure modes, effects and causes that hold up, ratings you can defend, and priorities that steer the design.

IEC 60812 · AIAG-VDA · 13 chapters · 2+ hrs of video

$1,500 aloneCourse details →
Step 3

Usability Engineering & Human Factors (UEHF)

Use-related risk, critical tasks, and formative and summative evaluations that prevent use errors.

IEC 62366-1 · FDA HF guidance · 9 chapters · about 16–20 hours

$1,500 aloneCourse details →
Step 4

Design Validation

Six validation types, from analytical to clinical, planned to show the device meets user needs the first time.

ISO 13485 7.3.7 · 12 chapters · about 16–20 hours

$1,500 aloneCourse details →

Design & Development first

Every later course builds on design inputs. Get the requirements and the file structure right, and the DFMEA, validation and usability work all have something solid to trace back to.

Then analyze, then prove

The DFMEA tells you where the design can fail and what to control. Usability Engineering makes sure real users can operate the device safely, and Design Validation then proves it meets their needs.

What changes

After the path, you will be able to

Design inputs · DDF/DHF

Write requirements a team can design to

Turn user needs into measurable design inputs and build the design and development file as the work happens, not after it.

DFMEA

Find failure modes before the design freezes

Build a Design FMEA with ratings you can defend, and use it to steer design decisions and verification.

IEC 62366-1 · FDA HF

Keep Use Errors out of the field

Identify critical tasks and run formative and summative evaluations that hold up in a submission.

Design Validation

Prove you built the right device

Plan the right validation type, justify sample sizes, and show the device meets user needs the first time.

Included in every course

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.

Course reviewer, on the DQS Process FMEA course

"Great material. Best I've ever seen in the industry."

Mike Z.Senior Management Consultant

For managers and team leads

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.

Email [email protected]

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.

Your instructor

Dr. John Salvato

Founder and President, Design Quality Services

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.

ISO 13485 Lead AuditorISO 14971FDA Design ControlsIEC 62304

"What we offer is capability-focused training. We understand the regulation, but we are also going to teach you how to implement it smartly."

Before you buy

Questions people ask

Do I have to take the courses in order?

No. You get access to every course in the path at once and can take them in any order. The order shown is the one we recommend, because each course builds on the one before it.

Can I buy the courses one at a time instead?

Yes. Bought separately, the 4 courses total $5,500. The path bundles them for $4,500, a $1,000 saving.

I already own one of these courses. Can I still get the path?

Yes. Email John at [email protected] and we will work out a fair price for the courses you don’t have yet.

How do I get support if I get stuck?

Each course includes live expert support from DQS, so you can ask about the material or how it applies to your own device.

Will I get a certificate?

Yes. Each course issues a completion certificate with the course, date and hours, ready for your ISO 13485 and QMSR training records.

Can my whole team take the path?

Yes. Email John to set up the path for your team. We can also invoice and accept purchase orders.

Design Engineering Leader: the whole path, one price.