Design Controls and ISO 14971 Risk Management Course
Learn design controls and ISO 14971 as one connected system, from user needs to a traceable design file, with templates and a worked example device.
Most device problems that reach auditors and regulators started as design problems: vague requirements, risks that never reached the design, or verification that did not prove what it claimed. This course teaches design controls and ISO 14971 risk management as one connected system, so your design file shows a clear line from user need to hazard to requirement to test result.
Who this course is for
- Product development, systems and mechanical or electrical engineers working on regulated devices.
- Quality and regulatory professionals who review design files or support audits and submissions.
- Software and SaMD teams who need to place their lifecycle inside a design control framework.
- Professionals moving into medical devices from other regulated or engineering industries.
What you will learn
| Module | Focus | What you can do afterwards |
|---|---|---|
| 1. Design control framework | ISO 13485 clause 7.3, FDA QMSR expectations, EU MDR Annex I and technical documentation | Explain what regulators expect from each design stage |
| 2. Planning and inputs | Design plans, user needs, testable requirements, regulatory and standards inputs | Write requirements that can be verified |
| 3. Outputs, review and traceability | Specifications, acceptance criteria, design reviews, traceability matrices | Build a matrix an auditor can follow in both directions |
| 4. ISO 14971 risk management | Risk management plan, hazard identification, risk estimation, evaluation, control, residual risk, benefit-risk | Create a risk file that drives design decisions |
| 5. Verification and validation | Test strategy, sample size rationale, usability validation, software and clinical links | Plan V&V that proves requirements and user needs |
| 6. Transfer, change and the design file | Design transfer, design changes, production and post-production risk feedback | Keep the design file current after launch |
How the course works
The course is built around a worked example device. You follow one product from user needs to a complete, traceable design file, using templates and exercises you can adapt to your own projects. Format, schedule and group size are agreed when you enquire, since individuals and company teams have different needs.
What you take away
- A requirements-to-test traceability structure you can reuse.
- A risk management file outline aligned to ISO 14971.
- A checklist for design reviews and for readiness before a regulatory submission.
- A clear picture of the questions auditors and reviewers ask about design.
Read before you enrol
These free guides cover the same ground at overview level: design controls for medical devices, risk management (ISO 14971), usability engineering and change control.
Frequently asked questions
Do I need prior medical device experience?
No. A background in engineering, quality or science helps, and the course starts from the fundamentals before moving to practical examples.
Does the course cover both FDA and EU requirements?
Yes. Design controls and ISO 14971 are common to both, and the course points out where FDA and EU MDR expectations differ.
Is this a professional certification?
No. It is a training course from AptSkill MedTech, an independent training provider. It does not lead to a regulator-issued or RAPS credential.
How do I get dates, format and fees?
Send an enquiry using the form below, and the team will reply with the current options.
Enquire about this course
Tell us your role, your goals and whether you are enquiring for yourself or a team.
Enquire about the Design Controls and ISO 14971 course
Ready to take the next step?
Questions? Email aptskill6@gmail.com and the AptSkill team will respond promptly.