Medical Device Development Primer | CPE

- Level: Intermediate
- CPE: 1.50 Credits
- Time: 57 Minutes
Explore the five critical stages that shape successful device development, from market evaluation and concept assessment to engineering design, manufacturing, and regulatory compliance with Medical Device Development Primer. Learn the ways risk analysis, FDA guidance, and reimbursement strategies influence go/no-go decisions.
- Become fluent in medical device development, from initial concept to design, testing, and manufacturing
- Gain insight into the regulatory, engineering, and clinical considerations influencing product success and market readiness
- Discover the strategic importance of usability, risk management, and design control in accelerating time-to-market and minimizing development risks
- Best Value: Unlimited Learning
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Get full access to this course with a one time purchase.
- 1-month access to all course material
- CPE credits included
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- Self-paced and on-demand
- Ideal for focused, one-off learning
- Overview
- Agenda
- Features
- Justify This Training
- FAQ
Watch Trailer
Agenda
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Market Opportunity Evaluation
Explains the evaluation of product value, user needs, and market opportunity to guide strategic decision-making.
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Concept Evaluation
Assesses the feasibility of a medical device’s design and outlines a process used to guide each step of product development.
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Engineering Design
Discusses how required medical device prototype specifications are designed, documented, and tested.
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Verification and Validation
Outlines the process of verification and validation in engineering builds, packaging, labeling, human factors testing, and manufacturing.
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Manufacturing Transfer
Examines the arduous process of moving from small scale to large scale production.
Features
- Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Transcripts in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Course materials
- Real-time tracking
- Progress reporting
- Accessibility features
- Corporate account upgrades
- LinkedIn certificate attachment
- Verified certificates
Justify This Training
View our “Justify This Training” checklist and letter to craft a persuasive request that clearly shows the value of Biotech Primer training to your role and your company. This step-by-step guide helps you highlight ROI, align with business goals, and increase your chances of getting this course approved.
FAQ
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