Recorded Medical Device Development Immersion

  • Course Price: $895 USD
  • Course Run Time: 10 hours
  • Course Level: Level 1 - Foundational
  • Completion Period: 3 month

This is the recorded Medical Device Development Immersion course which has the same content, interactive exercises, and course materials that are given in the live version. You have 3 months to view this course. 

Medical Device Development Immersion is a course designed for those who need to better understand all aspects of medical device development. Beginning with an overview of the medical device industry, the course quickly delves into the changing regulatory environment and the different regulatory pathways devices can undertake for FDA or EMA marketing approval. Attention is then focused on a detailed explanation of the five development phases—market opportunity, evaluation, design, verification, and manufacturing. The course ends with a brief look at commercialization, including reimbursement strategies. Learn from an industry expert with 30-years of experience in both large and start-up medical device companies. This is a recording of a Medical Device Development Immersion course given live.

Takeaways
  1. Fluency in the essential terminology and acronyms used in the medical device sector.
  2. Improved communication with engineers, regulators, colleagues, and clients.
  3. Ability to construct a medical device by following the traditional five phases of development.
  4. Understanding of the medical device approval pathways in both the USA and European Union.
  5. Conduct risk mitigation during medical device development.
Certificate Requirements
  • View entire course
  • Read all articles
  • Answer all knowledge check questions
Medical Device Overview
Knowledge Check
Regulatory Approval Pathways
Knowledge Check
Medical Device Regulation
Knowledge Check
Phase I: Market Opportunity Evaluation
Medical Device Development Exercise - Activity 1
Knowledge Check
Phase II: Concept Evaluation
Medical Device Development Exercise - Activity 2
Medical Device Development Exercise - Activity 3
Knowledge Check
Phase III: Engineering Design
Knowledge Check
Phase IV: Verification & Validation
Medical Device Development Exercise - Activity 4
Knowledge Check
Phase V: Manufacturing
Knowledge Check
Medical Device Approval
Knowledge Check
Commercialization
Knowledge Check
Linkedin Certificate Demo
Certificate Requirements
  • View entire course
  • Read all articles
  • Answer all knowledge check questions