Medical Device Development

  • Course Price: $150 USD
  • Course Run Time: 57 minutes
  • Course Level: Level 2 - General
  • Completion Period: 2 week

Medical Device Development provides a detailed look at the five stages of medical device development, including market opportunity evaluation, concept evaluation, engineering design, verification and validation, and manufacturing transfer. Understand the FDA guidances for process design, qualification, and monitoring. Learn how risk assessment, reimbursement, and the ability to scale-up manufacturing determine if a product development plan moves forward or not.

Takeaways
  1. Understand the importance of the five phases of medical device development.
  2. Learn how to evaluate the market opportunity for a novel medical device.
  3. Determine the manufacturing feasibility based on a medical device's design.
  4. Learn the required prototype specifications needed in device design, documentation, and testing.
  5. Explain the FDA validation guidance for process design, qualification, and monitoring.
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent
Download Agenda
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent
Trailer
Phase 1: Market Opportunity Evaluation
Explains how to evaluate the value and opportunity of the product, the user, and the market.
Phase 2: Concept Evaluation
Determines the feasibility of the medical device's conceptual design and how that blueprint is used to map out the key steps in product design.
Phase 3: Engineering Design
Discusses how required medical device prototype specifications are designed, documented, and tested.
Phase 4: Verification And Validation
Advocates for a process of verification and validation in engineering builds, packaging, labeling, human factors testing, and manufacturing.
Phase 5: Manufacturing Transfer
Shows the arduous process of how to move from small scale to large scale production.
Final Quiz
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent