Biotech Primer Institute

Medical Device Overview & Regulation

27 STUDENTS ENROLLED

Course Availability: Unlimited views for 72 hours from time of purchase
Course Running Time:
54 minutes | Assessment: 20 minutes
Course Material: Downloadable PDF of all presented slides
Preview Now: Medical Device Risk Management Plan

Medical Device Overview & Regulation defines the term medical device and explores the diversity of the industry by highlighting its various sectors and top companies. Device classification and differing approval pathways are discussed in detail. The course concludes with a discussion of quality system regulations and risk management plans. Acquire an understanding of the medical device industry’s breadth with this course.
Running time: 54 minutes | Assessment: 20 minutes

Medical Device Overview
At the end of this section you should be able to:
1. Identify the major sectors and top companies of the medical device industry
2. Understand the history of medical device regulation

FDA Medical Device Classification
At the end of this section you should be able to:
1. Diagram the FDA organizational structure for medical device
2. Classify medical devices into Class I, II, III based on risk assessment

FDA Approval Pathways for Medical Device
At the end of this section you should be able to:
1. Identify the major medical device approval pathways
2. Define predicate device

FDA Regulatory Compliance for Medical Device
At the end of this section you should be able to:
1. Explain how the Code of Federal Regulations (CFR) enforces regulatory compliance
2. Convey the purpose of Good Lab Practices, Good Clinical Practices, current Good Manufacturing Practices
3. Describe what parts of the business and manufacturing practices must follow QSR protocols

Medical Device Risk Management Plans
At the end of this section you should be able to:
1. Develop a risk management plan for a medical device

Medical Device Regulatory Bodies Worldwide
At the end of this section you should be able to:
1. List the worldwide regulatory bodies for medical devices

Course Reviews

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  1. Unclear instructions

    2

    While the course was informative, the instructions for the assessment quiz were very unclear. Because I did not understand that I had to save each answer before submitting the quiz (and because there was no warning before submission), I was given a zero on the course. It is disappointing to spend my and my company’s resources on such a course and to have nothing to show for it.

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