ISO 13485 Certification Test

The ISO 13485 Certification Test is a free intermediate-level, 20-minute skill test from Science of Apps. It tests ISO 13485:2016 medical device quality management knowledge — QMS fundamentals, documentation and management responsibility, design and development, purchasing and production controls, risk management with ISO 14971, and measurement, CAPA, audits and regulatory alignment including the FDA QMSR and MDSAP — written to ISO 13485, ISO 14971 and FDA guidance for 2026. Score 70% or more on its 20 questions to earn a verifiable ISO 13485 QMS certificate (SOA-I1). Every question is based on published standards and research — including ISO 13485:2016 Medical devices — Quality management systems (ISO), ISO 14971:2019 Medical devices — Application of risk management to medical devices (ISO), Medical Device Single Audit Program (MDSAP) (US FDA / IMDRF regulators) — and each answer is explained with its source.

Take the free ISO 13485 Certification Test on Science of Apps. It tests quality management for medical devices, design controls, and risk management (ISO 14971) against a 2026–2027 syllabus, and passing earns a verifiable certificate you can add to LinkedIn.

Read the four skill areas on this page, then take the 20-minute test online — no fee, course or sign-up. You see every answer explained when you finish. Score 70% or more and you get a ISO 13485 QMS certificate straight away, on screen, as a PDF and by email, with a credential ID anyone can verify.

Yes. The questions are original scenarios written by Science of Apps, and each one is based on a public source you can read: ISO 13485:2016 Medical devices — Quality management systems (ISO); ISO 14971:2019 Medical devices — Application of risk management to medical devices (ISO); Medical Device Single Audit Program (MDSAP) (US FDA / IMDRF regulators); Quality Management System Regulation (21 CFR 820, aligned with ISO 13485) (US Food and Drug Administration). The source is shown under each question and linked in the answer review. Science of Apps doesn't copy questions from other tests.

Four skill areas with five questions each, drawn from a bank of 10 per area so a retake brings new questions: QMS Fundamentals and Management Responsibility (Scope and processes, Documentation and Management review); Design, Purchasing and Production Controls (Design and development, Purchasing and Production and validation); Risk Management with ISO 14971 (Risk process, Risk control and Benefit-risk); Measurement, CAPA, Audits and Regulatory Alignment (Feedback and complaints, CAPA and Audits and regulators). Every question is an original scenario written to the 2026–2027 standard, with the published source named under it.

Quality engineer, Regulatory affairs specialist, Internal auditor, Medical device engineer and QA manager. It suits anyone who wants a quick, verifiable way to show ISO 13485 knowledge in 2026 and 2027, from students and career switchers to experienced professionals.

ISO 13485 is a voluntary standard, but it is the basis for EU MDR conformity, Health Canada's MDSAP requirement and, since February 2026, the US FDA's Quality Management System Regulation (QMSR), which incorporates it by reference.

ISO 13485 is tailored to medical devices: it emphasises regulatory requirements, risk management, documentation and product safety, and drops ISO 9001's focus on continual improvement and customer satisfaction as goals in themselves.

Yes. The test is online, in English and free everywhere — people take it from India, the US, the UK, Europe, Africa, Latin America and Asia-Pacific. Your certificate is dated with your own local date and can be verified from anywhere at scienceofapps.com/certification/verify/.

20 questions — 5 from each of 4 skill areas — with a 20-minute limit. You need 70% (14 of 20) to pass and 90% for distinction.

We rate it Intermediate: assumes hands-on experience in the role. It has 20 scenario questions — 5 from each of 4 skill areas — and a 20-minute limit. You need 70% (14 of 20) to pass and 90% for distinction.

Nothing. There is no fee to take a test, to receive the certificate, to have it emailed or to verify it, and no sign-up.

On our server, not in your browser. The answers never reach the page until you submit, so a certificate can only be earned by passing. Each certificate gets a unique credential ID stored by Science of Apps.

You see your score for each area and every question with the correct answer and why, with the published source behind it. You can retake after 30 minutes, and the retake draws questions you haven't seen yet.

No. Every certificate is dated, so it always shows when you passed. Retake a test any time for a newer date or a higher score.

Yes. After you pass, Add to LinkedIn opens the Licenses & certifications form with the certificate name, Science of Apps as the issuer, the issue date, your credential ID and the verification link filled in. You can also download it as a PDF or PNG, and it's emailed to you as a PDF.

Every certificate has a credential ID and a QR code. Scanning it, or entering the ID at scienceofapps.com/certification/verify/, shows the holder's name, the certification, the score and the issue date from our records.

No. They are Science of Apps' own assessments of applied skill. They aren't issued by a university or standards body, and they work best alongside a portfolio that shows the skills in real work.