| 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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