Medical Device Development Course | Medical Device Courses

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