CAS-13485-AW

ISO 13485:2016 Medical Devices Quality Management — Awareness

Awareness of ISO 13485:2016 Medical Devices Quality Management — terminology, structure, intent of clauses and how the organization is affected.

Training delivered under ISO 21001:2025 — together, CAS Academy.

Programme types

Just Training

16 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

Validity1 year

Recertificationevery 1 year(s)

Surveillancenot required

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.