ISO 13485 Awareness
- Purpose and structure of ISO 13485
- Key requirements
- Each person's role in the system
- Benefits and common pitfalls
For: All staff, managers and new joiners
Virtual $195 · In-person $245
Book or enquire
Training Academy
ISO 13485 Training
ISO 13485:2016
Medical device quality training for quality, regulatory and production teams, covering risk management, design controls and links to EU MDR and the FDA QMSR.
Training pathway
Three courses, one pathway
Regulators expect competent people at every step. Train staff in Awareness, QA and RA leads as Implementers and internal auditors.
ISO 13485 Implementer
- Context, scope and leadership for ISO 13485
- Risk-based planning and controls: risk management and design controls
- Documented information that fits your practice
- Internal audit, management review and readiness
For: System owners and implementation leads
Virtual $1,195 · In-person $1,395
Book or enquire
ISO 13485 Internal Auditor
- Audit principles and ISO 19011
- Auditing ISO 13485 requirements
- Planning, interviewing and sampling evidence
- Writing findings and following up actions
For: Internal audit teams and system coordinators
Virtual $795 · In-person $895
Book or enquire
Prices
One price list for every standard
| Course | Duration | Virtual live | In-person public |
|---|---|---|---|
| Awareness | Half day | $195 | $245 |
| Implementer | 3 days | $1,195 | $1,395 |
| Internal Auditor | 2 days | $795 | $895 |
| Lead Auditor (CQI/IRCA certified) | 5 days | $2,295 | $2,495 |
Prices in USD per participant, excluding local taxes. 10% off for five or more participants from one organisation. In-house courses are quoted. Regional pricing may apply in South Asia and the GCC. Lead Auditor courses are available for ISO 9001, ISO 14001, ISO/IEC 27001 and ISO 45001.
Delivery
Train the way that suits your team
In-house
Delivered at your site, tailored to your processes and risks.
Public courses
Scheduled open courses for individuals and small teams.
Virtual & hybrid
Live online delivery across time zones, or blended formats.
Assessment
Exercises, case studies and certificates of achievement, verifiable online.
Why train with AEC
Practitioners in the room
Practitioner trainers
Every trainer is a registered lead auditor who audits in the field, not just in the classroom.
Real-world cases
Exercises drawn from energy, manufacturing, food, technology and public-sector audits.
Recognised credentials
CQI/IRCA certified Lead Auditor courses, and certificates you can verify on our website.
Questions
ISO 13485 training FAQ
Does the course cover the FDA QMSR?
Yes. We explain how the FDA Quality Management System Regulation incorporates ISO 13485:2016 from February 2026.
Is the course suitable for suppliers to device makers?
Yes. Component and service suppliers often need the same understanding of ISO 13485 as manufacturers.
How do I verify a training certificate?
Every AEC training certificate can be checked on our certificate verification page using the certificate number.
Plan ISO 13485 training for your team
Tell us how many people, which course and your preferred format. We reply with dates and a proposal, including in-house options.