Biotech Primer Institute

Medical Device Development

12 STUDENTS ENROLLED

Course Availability: Unlimited views for 72 hours from time of purchase
Course Running Time:
57 minutes | Assessment: 20 minutes
Course Material: Downloadable PDF for all presented slides
Preview Now: Phase 1: Market Evaluation

Medical Device Development gives a detailed overview of the five stages of medical device development: market opportunity evaluation, concept evaluation, engineering design, verification and validation and manufacturing transfer. Broaden your understanding of the entire development process with this course.
Running time: 57 minutes | Assessment: 20 minutes

Phase 1: Market Evaluation
At the end of this section you should be able to:
1. List the five stages of medical device development
2. Evaluate market opportunities plan using customer requirements, product description, reimbursement information, and risk analysis

Phase 2: Concept Evaluation
At the end of this section you should be able to:
1. Evaluate feasibility of products conceptual design
2. Identify the key steps in product design

Phase 3: Engineering Design
At the end of this section you should be able to:
1. Design, document, and test prototypes
2. Understand the importance of defining product requirement specifications

Phase 4: Verification & Validation
At the end of this section you should be able to:
1. Explain the process of verification and validation for engineering builds, packaging, labeling, human factors testing, and manufacturing

Phase 5: Manufacturing Transfer
At the end of this section you should be able to:
1. Explain the process of manufacturing transfer from small scale to large scale

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