CAS-13485-IMP

ISO 13485:2016 Implementer

Certifies the competence of a Implementer to advise on, design and implement ISO 13485:2016 (Medical Devices — Quality Management Systems), applying the consultancy guidance of ISO 20700:2017.

Training delivered under ISO 21001:2025 · Examination & certification under ISO/IEC 17024:2026 — together, CAS Academy.

Programme types

Just Training

32 hours · ISO 21001:2025

Just Examination

Exam only · ISO/IEC 17024:2026

Hybrid

Training + examination

Choose your programme type in the form. Contact us for pricing.

Certificate

TypeAttendance · Examination · Both

Validity3 years

Recertificationevery 3 year(s)

Surveillancenot required

Prerequisites

Relevant subject-matter experience; advisory or implementation experience is recommended.

Your application

Tell us about yourself and we’ll confirm prerequisites within 2 working days. Fields marked * are required.

1. Choose your programme type

Delivery mode

2. Who's applying

Application path *Individual — I'm applying for myselfCorporate — my employer is sponsoring me (the company will be invoiced)

Your details

Your personal details — you'll be the certified person.

Full name *

Email *

Phone (optional)

Preferred exam language

3. Personal information

National ID

Passport number

Date of birth

Nationality

Address

City

Country

4. Prerequisites & equivalent training (§5.2.3 d, §9.2.2 d)

How do you meet the scheme prerequisites? *

Education summary

Relevant experience

I have completed equivalent training elsewhere (not from CAS Academy).

5. Supporting documents

PDF / DOCX / PNG / JPG / WebP, ≤ 10 MB each. All optional at submission — staff may request follow-up documents.

Curriculum vitae (CV)

National ID or passport

Education certificates

Experience letters

Equivalent training certificate (if applicable)

6. Reasonable accommodation (§9.1.5)

I would like to request reasonable accommodation for the assessment.

7. Acknowledgements

I agree to comply with the certification requirements and to provide any information needed for the assessment (clause 9.2.2 c).I have read the privacy notice and consent to CAS handling my personal data as described.