Design and Development for medical devices · Self-paced

Tame the chaos of device development and get to market.

Plan the project, turn User Needs into measurable Design Inputs, run Design Reviews, then verify, validate and transfer with the traceability regulators expect, practiced step-by-step on a practice device.

Enroll for $1,000Try Chapter 1 free

Training a team or paying by purchase order? Email us

14 chapters · about 16–20 hours · the foundation of the DQS library

Top Medical Device Consulting 2026 award badge from MedTech Business ReviewTop Medical Device Consulting 2026 MEDTECH Business ReviewHands-on with a practice device Exercises and recaps in six chapters
One traceability line, wearable monitorIllustrative example
Typical entry
User Need
Easy to carry
Design Input
Lightweight
Verification
See test report
Trace
Not measurableTrace breaks
After this course
User Need
Patient wears the monitor all day during normal activity
Design Input
Mass of 250 g or less, including battery
Verification
Mass test on production-equivalent units
Trace
UN → DI → DOVerified and validatedAudit-ready
Practice device exercises take you through each step, from User Needs to Design Validation.
Sound familiar?

The Design & Development File exists. It just doesn't tell the story.

  • The Design and Development Plan was written once and never updated.
  • User Needs and Design Inputs can't be measured, so verification proves nothing.
  • Design Reviews are status meetings, not real reviews of the design.
  • Traceability breaks between Design Inputs and test reports, and the file is assembled the week before the audit.

That isn't a lack of effort. It's the lack of a phased process that connects needs, design, evidence and documentation. This course teaches that process.

Check your design file

How does your design file hold up?

Answer for the most recent device your team took through Design and Development. Your answers stay on this page and aren't sent anywhere.

  1. Is your Design and Development Plan updated as the project changes?
  2. Can every Design Input be measured or verified, with a number and a method?
  3. Do your Design Reviews challenge the design, with an independent reviewer and tracked actions?
  4. Can you trace each User Need through Design Inputs and Outputs to a verification or validation result?
  5. Is your Design & Development File kept current as the work happens?
Course reviewer, on the DQS Process FMEA course
"Great material. Best I've ever seen in the industry."
Mike Z.Senior Management Consultant
What changes

After the course, your team will be able to

Design and Development Plan

Plan a project that stays on track

Build plans that set scope, team responsibilities, interfaces, schedules and Risk Management strategy, and keep them current as the project moves.

User Needs · Stakeholder Needs · Design Inputs

Turn needs into measurable requirements

Gather User and Stakeholder Needs, then translate them into Design Inputs that are measurable and verifiable.

Design Review · Risk Management · Design Outputs

Build a design that proves itself

Run effective Design Reviews, apply Risk Management and FMEA, and identify Essential Design Outputs with complete traceability.

Verification · Validation · Transfer · Change

Get to market and stay compliant

Verify and validate the design, transfer it to production, control changes, and keep a Medical Device File that tells a clear story.

Is this right for you?

Built for the people who bring medical devices to market

See who it's for, and who it isn't

This course is for you if

  • You are an engineer new to medical devices and need to understand Design and Development end to end.
  • You work at a start-up building its first Design & Development File.
  • You lead R&D projects and want a phased process that keeps development on schedule.
  • You work in quality or regulatory and review design files before audits and submissions.
  • You want one consistent process across every product and team.

It is probably not for you if

  • You want a one-hour overview of design controls vocabulary.
  • You are looking for procedure templates without changing how your team develops products.
How the course is built

Four stages, from project plan to Medical Device File

Core chapters include hands-on work on a practice device, plus quizzes to confirm you have it before moving on.

Stage 1

Plan

The regulatory requirements behind Design and Development, planning the project, and a worked example.

Chapters 1–3
Stage 2

Define

User and Stakeholder Needs, measurable Design Inputs, and Design Reviews that actually review the design.

Chapters 4–6
Stage 3

Design and prove

Risk Management, Design Outputs and Essential Design Outputs, then Design Verification and Design Validation.

Chapters 7–10
Stage 4

Transfer and sustain

Design Transfer, Design Changes, technical writing, and a Medical Device File that holds up.

Chapters 11–14
  • 16–20 hrs of learning in 241 lessons
  • Quizzes throughout, plus a final exam
  • Practice device exercises and recaps in six chapters
  • Downloadable course materials

Not sure yet? Start Chapter 1 free. You get access inside the course as a student before you decide.

Chapters marked "Your gap" match the answers you gave in the design file check.

  1. Introduction to Design and DevelopmentYour gap
  2. Design PlanningYour gap
  3. Design and Development ExampleYour gap
  4. User Needs and Stakeholder NeedsYour gap
  5. Design InputsYour gap
  6. Design ReviewYour gap
  7. Risk ManagementYour gap
  8. Design OutputsYour gap
  9. Design VerificationYour gap
  10. Design ValidationYour gap
  11. Design TransferYour gap
  12. Design ChangesYour gap
  13. Technical WritingYour gap
  14. Design DocumentationYour gap
For managers and team leads

Development is a team effort. Train the team on one process.

When R&D, quality and regulatory share the same phased process, plans stay current, reviews catch problems early, and the design file is ready before the auditor asks.

  • A shared vocabularyOne way to write needs, inputs and outputs across every product and team.
  • The foundation for the libraryDesign Validation, Design FMEA, Safety Risk Management and Usability Engineering courses go deeper on each step.
  • 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, founder of Design Quality Services
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 and Development processes for device makers around the world, from start-ups to global manufacturers, 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 enroll

Questions people ask

Can I try it before I buy?
Yes. Start Chapter 1 free. You get access inside the course as a student and work through the full chapter before you decide.
How much time does it take?
Plan on about 16 to 20 hours. The course is self-paced across 14 chapters and 241 lessons, and much of that time goes into the practice device exercises rather than video. You have 60 days of access, plus a live discussion with a DQS expert to make sure the concepts are clear.
Is this the same as design controls?
Yes. FDA calls it design controls and ISO 13485 calls it design and development. The course covers the full process those requirements describe, from planning through Design Transfer and Design Changes.
How does it fit with the other DQS courses?
This is the foundation. It covers every step at the right depth for running a project. The Design Validation, Design FMEA, Safety Risk Management and Usability Engineering courses then go deeper on individual steps.
Does it cover Design Transfer and change control?
Yes. Chapters 11 and 12 cover transferring the design to production with a systematic procedure and controlling Design Changes throughout the device lifecycle.

Bring your next device to market with a process that holds up.

Learn a Design and Development process your team can defend in every design review, audit and submission.

$1,000 · self-paced · start today

Enroll nowTry Chapter 1 free

Training a team or paying by purchase order? Email us