- Introduction
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Course goals
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Welcome
- The regulatory world
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What is a medical device?
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Quiz - What is a medical device?
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Medical device terminology
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Quiz - Medical device terminology
- Quality requirements
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The regulatory background
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Quiz - The regulatory background
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Standards
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Quiz - Standards
- Audits and inspections
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Introduction to audits
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Quiz - Introduction to audits
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Quality concepts and audits - Part 1
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Quality concepts and what to say - Part 2
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Quiz - Quality concepts
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Unannounced audits
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Quiz - Unannounced audits
- Complaints and vigilance
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What is a complaint?
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Quiz - What is a complaint?
- Design control
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The product development process - Part 1
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The product development process - Part 2
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Quiz - The product development process
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Product documentation
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Quiz - Product documentation
- Risk management and usability
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Introduction to risk management
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Quiz - Introduction to risk management
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Introduction to usability engineering
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Quiz - Introduction to usability engineering
- Production and infrastructure
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Keeping things clean and functional
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Quiz - Keeping things clean and functional
- Regulatory affairs
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Product approval EU
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Product approval US
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Quiz - Product approval US
- Post market surveillance
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Post market surveillance
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Quiz - Post market surveillance
- Final exam
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Final exam - Working in the Medical Device Industry
- Course evaluation
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Course evaluation - Working in the Medical Device Industry
Introduction to Working in the Medical Device Industry
Prepare yourself for working in the medical device industry with this introductory, self-paced online course.
This online course focuses on making it easier for you to start working in the medical device industry by providing you with a general understanding of the industry including key concepts and terminology.
The course covers an introduction to medical devices, the Quality Management System, how to behave during audits, risk management, design control and usability engineering, complaints and vigilance, how to behave in controlled environments, including clean rooms, and many other important areas.
Learners will have access to the online course for 6 months to review the material and pass the exam. One exam attempt is included and the score earned will be printed on the learner's certificate.
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