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Table of Contents
Table of Contents
Bridge the gap between engineering innovation and patient safety by mastering the complete device development lifecycle from concept to market clearance.
What You Will Learn
- 1 Understand the medical device development lifecycle from concept to market.
- 2 Learn regulatory pathways including FDA 510(k) and PMA.
- 3 Apply quality management systems (ISO 13485) to device development.
- 4 Analyze risk management per ISO 14971.
- 5 Design and develop software for medical devices (IEC 62304).
- 6 Implement usability engineering to ensure patient safety.
- 7 Conduct clinical evaluations and post-market surveillance.
- 8 Manage medical device cybersecurity.
- 9 Develop labeling and instructions for use.
- 10 Prepare for regulatory audits and certification.
What's Included
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Medical Device Development