ISO 13485:2016 Consultant
A consultancy-level course for ISO 13485:2016 (medical-device quality management), aligned with ISO 20700 — building the competence to advise on the system as a consultant.
Duration
40 hours
Delivery
Virtual or physical
Language
English
Outcome
Examined certificate
Training delivered under ISO 21001:2025 · Examination & certification under ISO/IEC 17024:2026 — together, CAS Academy.
Overview
Training programme for the Consultant scheme on ISO 13485:2016 (Medical Devices — Quality Management Systems). Delivered under ISO 21001:2025; examination under ISO/IEC 17024:2026.
Certifies the competence of a Consultant to advise on, design and implement ISO 13485:2016 (Medical Devices — Quality Management Systems), applying the consultancy guidance of ISO 20700:2017.
What you'll learn
On completion the participant will be able to apply ISO 13485 consultant responsibilities in the workplace.
- Diagnose gaps against ISO 13485:2016 with a structured, evidence-based assessment.
- Design pragmatic, right-sized implementation roadmaps.
- Advise on documented information, process design and risk-based thinking.
- Coach teams through adoption, internal audit and management review.
- Manage the engagement from kick-off to certification readiness.
Who should attend
Tertiary education; 3+ years of relevant management-system implementation experience.
- Independent consultants and advisory professionals.
- In-house experts and implementers supporting the system.
- Anyone advising on or implementing ISO 13485:2016.
How it's delivered
Format
40-hour programme, attend virtual — live online — or physical, in person.
Materials & trainer
Led by an approved CAS Academy trainer, with full course materials and worked examples.
Examination
A proctored examination under ISO/IEC 17024:2026 leads to the certificate.
Reasonable accommodation
Tell us at application and we'll arrange suitable accommodation for the assessment (§9.1.5).
The certificate you earn
Every certificate is verifiable online at academy.cas.com.eg/verify. CAS Academy operates to ISO/IEC 17024:2026 — accreditation in progress.
Prerequisites
Tertiary education; 3+ years of relevant management-system implementation experience.
Reference standards
Frequently asked questions
How long is the ISO 13485:2016 Consultant programme and how is it delivered?
It runs over 40 training hours, and you can attend virtual — live online — or physical — in person at an agreed venue.
How much does the ISO 13485:2016 Consultant programme cost?
The fee depends on your chosen programme type (Just Training, Just Examination or Hybrid) and delivery (virtual or physical). Apply or contact CAS Academy and we'll confirm your fee.
Is there an examination, and what certificate do I receive?
Yes. You sit a proctored examination and, on a successful result, receive a CAS Academy personnel certificate carrying ISO 21001:2025 (training) and ISO/IEC 17024:2026 (examination). It is valid 3 years, with recertification every 3 years.
Do I need any prerequisites for ISO 13485:2016 Consultant?
Tertiary education; 3+ years of relevant management-system implementation experience.
How do I enrol?
Apply online from this page. We confirm prerequisites within 2 working days, then schedule your training and examination.
Related programmes
ISO 13485:2016 Advisor
Read more →AuditorISO 13485:2016 Auditor
Read more →AwarenessISO 13485:2016 Medical Devices Quality Management — Awareness
Read more →ExpertISO 13485:2016 Expert
Read more →Internal AuditorISO 13485:2016 Internal Auditor
Read more →ImplementerISO 13485:2016 Implementer
Read more →Ready to enrol on ISO 13485:2016 Consultant?
Apply online and we’ll confirm your prerequisites within 2 working days.