Medical Device Development Course

Module 1 Course Discussion Forums
Unit 1 Forums - Medical Device Development
Module 2 Introduction to Medical Device Development
Unit 1 Introduction to Medical Device Development
Module 3 Project Management for Medical Devices - How Corporations Manage Projects
Unit 1 Project Management 101
Unit 2 Project Lifecycle and Initiation
Unit 3 Project Planning
Unit 4 Project Executing, Control, and Closing
Module 4 Pre-clinical Device Development – Research projects
Unit 1 Pre-Clinical Research Projects
Unit 2 Managing in vivo Studies
Unit 3 Pre-clinical Research Resources
Module 5 Regulatory Basics for Medical Devices
Unit 1 Regulatory Considerations and the FDA
Unit 2 Regulation of Medical Devices in the USA
Unit 3 Role of The Regulatory Department
Unit 4 Regulatory Affairs Resources
Module 6 Quality Control and Quality Assurance
Unit 1 Quality Control and Quality Assurance
Unit 2 The Quality System
Unit 3 QA/QC Resources
Module 7 Business 101 – What makes corporations tick and research labs tock
Unit 1 Business 101
Unit 2 Types of Corporations, Part 1
Unit 3 Types of Corporations, Part 2
Unit 4 Analyzing Companies
Module 8 Marketing medical devices, and the basics of sales forces
Unit 1 Marketing and Sale of Medical Devices
Unit 2 Marketing Strategy and Mix
Unit 3 Role of the Marketing Department
Unit 4 Product Management
Unit 5 The Basics of Sales Forces
Module 9 Clinical Research
Unit 1 Clinical trials, CRA’s, and CRO’s
Unit 2 Roles in Clinical Trials
Unit 3 Clinical Research Resources
Module 10 Design Controls 101
Unit 1 Design Controls Part 1: DHF, Proposal, DDP, Inputs, Outputs, Specifications
Unit 2 Design Controls Part 2: Design Verification
Unit 3 Design Controls Part 2: Design Validation
Unit 4 Design Controls Part 2: Design Transfer, Review, and Change
Unit 5 Medical Device Development - The Project Definition Form
Unit 6 Design Controls Resources
Module 11 Risk Analysis for Medical Devices
Unit 1 Risk Analysis: FMECA, Risk analysis document
Unit 2 Risk Management Resources
Module 12 Organizational Development in Device Companies
Unit 1 Organization types, putting together project teams
Unit 2 Project Management vs. Design Controls
Module 13 Consultants and Some Legal Basics
Unit 1 Consultants – Role in medical device development, Anti- kickback statute
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