QA Smart QA Academy

Pass the audit. Pass the exam.
Learn medical device QA/RA by doing.

Practice questions, case simulations and AI-marked written tasks for ISO 13485, EU MDR, MDSAP and the AI Act. Every answer option explained.

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Courses

Basic to expert levels, each with chapter quizzes and a level exam.

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ISO 13485 Practice Questions

Quality management systems for medical devices: documentation, CAPA, audits, supplier control.

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EU MDR & IVDR Quiz

Classification, technical documentation, clinical evaluation, post-market surveillance.

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MDSAP Audit Simulation

Single audit, five jurisdictions. Walk through realistic audit scenarios.

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AI in Medical Devices

EU AI Act, SaMD, validation, cybersecurity and post-market for AI-enabled devices.

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GDPR & HIPAA for QA/RA

Health data privacy essentials for regulated medical device teams.

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Trading Basics

Candlesticks and chart reading. Educational only, not financial advice; trading involves risk of loss.

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Fictional scenario. Every option is explained, right or wrong.

During an internal audit at a fictional device maker, an auditor finds a calibration record that is two months overdue for a measuring instrument used in final release. What is the best first action?

What others lack

Most courses are slides and a multiple-choice test. Here is what we add.

FeatureTypical courseSmart QA Academy
AI-marked written tasks (upload a Word file)NoYes
Case simulations with realistic scenariosRareYes
Every quiz option explained, right or wrongRight answer onlyYes
Chapter quizzes and level exams in one pathSeparateYes
Free module intros on YouTubeSales pitchYes

Free module intros

Picture-first videos with a sample quiz. Watch on our YouTube channel.

Questions

Is this an official accreditation?

No. It is educational content, not legal advice and not an official accreditation.

How are written tasks marked?

Upload a Word document and receive rubric-based AI feedback.

Do you copy standards text?

No. Standards are paraphrased and every example is fictional. No client names or logos.

When can I enroll?

The Academy is open for preview now. Pricing and enrollment will be announced on this site and on YouTube.