ASQ CBA – Certified Biomedical Auditor (Exam Preparation)
Preparation for the ASQ CBA exam: medical device regulations, ISO 13485, risk management and auditing techniques.
At a glance
- 5 days
Who it's for
- Medical device quality professionals
- Auditors and regulatory staff
- Candidates for the ASQ CBA exam
Learning objectives
- Cover the ASQ CBA Body of Knowledge
- Understand key medical device regulations
- Audit against ISO 13485 and risk management
- Practise exam questions
Detailed content
- FDA QSR and EU MDR overview
- Registration basics
- Post-market duties
- Design controls
- Production controls
- CAPA
- ISO 14971 process
- Risk control
- Usability
- Audit planning and sampling
- Evidence and reporting
- Mock exam
Day-by-day agenda
A typical schedule. In-company versions are tailored to your processes, data and timing.
- Medical device regulations
- ISO 13485
- Risk management
- Auditing techniques
- Practical workshop applying the tools to participants' cases
- Mock exam, review of weak areas and exam strategy
Practice, tools and assessment
Hands-on practice
- Audit simulation: plan, interview, sample evidence and write findings
- Gap analysis of your own documents against the clauses
- Write nonconformity statements and review corrective actions
- Mock regulatory inspection of a GMP area
Tools and templates you keep
- Clause-by-clause gap-analysis checklist
- Audit plan, checklist and report templates
- Nonconformity and CAPA log
- Deviation, CAPA and change-control forms
How learning is assessed
- Diagnostic test on day one to focus study time
- Chapter quizzes and a full timed mock exam in the official format
- Personal study plan until your exam date
Built on these standards and bodies of knowledge
- ISO 9001:2015 + Amd 1:2024
- ISO 19011:2018 (auditing management systems)
- ISO/IEC 17021-1 (certification bodies)
Certificate
Participants who complete the program and its assessment receive a certificate from The Excellence Center, which can be verified online.
The exam is set and the credential awarded by ASQ. The Excellence Center provides preparation; it does not award ASQ credentials.
This program prepares for a certificate from a body on the Saudi HRDF (Hadaf) Professional Certificates list. Saudi citizens may be able to claim a fixed reimbursement of the certificate cost from HRDF: up to two certificates per person, after passing the exam, if the certificate is on HRDF's current list and the employer did not pay for it. HRDF approves the certificate, not the training provider. Check the HRDF website before enrolling. All HRDF-listed programs · Enrol in Saudi Arabia with our partner Elm E · HRDF
New in our 2026 portfolio — tell us your dates and we will confirm the trainer and schedule.
How it is delivered
- Public courses in Cairo, in-company programs and live online training
- Practical exercises, case studies and examples from your sector
- Can also run as Train & Stay in Sharm El Sheikh, Hurghada or Cairo
Frequently asked questions
How long is ASQ CBA – Certified Biomedical Auditor (Exam Preparation)?
The program runs 5 days. In-company versions can be adapted to your needs.
Is the course taught in Arabic or English?
Sessions are usually delivered in Arabic with English technical terms and materials. Full English delivery is available for in-company groups.
Can you run it inside our company?
Yes. In-company programs use exercises built on your own processes. Tell us the group size and preferred timing and we will send a proposal.
Will I receive a certificate?
Participants who complete the program and its assessment receive a certificate from The Excellence Center, which can be verified online.
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