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ESPAST · PARIS · Online course
Medical Device Compliance Engineering Foundations
Explore Medical Device Compliance Engineering Foundations through four introductory topics: Device classification and compliance concepts · Quality and risk management · Technical documentation and traceability · Post-market surveillance and compliance cases. The course combines reading, cases and exercises to introduce the subject and its main applications.
Course topics
01
Device classification and compliance concepts
02
Quality and risk management
03
Technical documentation and traceability
04
Post-market surveillance and compliance cases
Assessment and certificate
Complete the reading and exercises and pass the final knowledge assessment. Assessment formats and pass criteria are provided in the learning instructions before the course starts. A digital completion certificate is awarded after passing.
Study arrangements
Learning is primarily through English-language text. Other language requests are considered during review. After payment, registration is reviewed within two working days; approved applicants receive the learning link and account access instructions by email. The course start and access arrangements are confirmed after approval.
The 15 hours are estimated total learning time, including reading, exercises and assessment; they are not video hours. The €90 fee includes learning, assessment and a digital completion certificate after passing.
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