BIO Professional Development
Through a curated network of education alliance partners, BIO offers industry professionals executive training and development resources for accelerating career growth
Medical Device Development Primer
Medical Device Development Primer broadly explores the five pivotal stages of medical device development. This class focuses on the workflow at each step, from evaluating market opportunities and rigorously assessing concepts to crafting engineering designs and scaling manufacturing. This primer unlocks the secrets of FDA guidance's pertaining to process design, qualification, and monitoring. It ends with a look at product risk assessment and reimbursement, summarizing their role in management's momentous go/no-go decisions. Enroll today to embark on this exciting quest toward groundbreaking medical device development!
Takeaways
- List the five phases of medical device development in order.
- Explain the techniques to effectively evaluate the market opportunity for a novel medical device.
- Determine the manufacturing feasibility by analyzing a medical device's design.
- Recommend required prototype specifications needed in medical device design, documentation, and testing.
- Explain the FDA validation guidance for process design, qualification, and monitoring.
Certificate Requirements
Complete the course quiz with a passing score of 75% or higher
Discover the expanding molecular diagnostics field, saving lives by pinpointing disease causes and guiding personalized treatments."
Explore diagnostic accuracy measurements: false negatives, false positives, variability, sensitivity, specificity. Essential for regulatory approval."
Explore US medical device regulation: classification, approval pathways, FDA guidelines, quality regulations, risk management.
Explore PCR, microarrays, gene sequencing & microRNA in diagnostics. Learn machines, workflow & result interpretation.
Discover the expanding molecular diagnostics field, saving lives by pinpointing disease causes and guiding personalized treatments."