Self-Paced · Online

e-Training Courses

Structured, self-paced online courses covering the international standards that govern medical device software and quality. Study at your own pace, test your knowledge with a timed assessment, and download a certificate of completion.

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IEC 62304 · Edition 1

The international standard for medical device software lifecycle processes. 13 process areas across Clauses 4–9, safety-class filtering, worked example deliverables, a timed assessment, and a downloadable certificate.

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IEC 62304 · Edition 2

The next edition of IEC 62304 is under active development at IEC TC62. This course will be published once the new edition is released.

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IEC 82304-1

Health software product safety — the companion standard to IEC 62304 covering software as a medical device and health software more broadly. Course in development.

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