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Medical Device Development - And Beyond
Introduction
Introduction (2:42)
1. Business 101 - What makes a corporation tick and research labs tock
Business 101 (6:42)
Types of Corporations, Part 1 (15:39)
Types of Corporations, Part 2 (15:58)
Analyzing Companies (10:49)
Quiz 1
2. Marketing of medical devices, and the basics of sales forces
Marketing and Sale of Medical Devices (13:40)
Marketing Strategy and Mix (13:05)
Role of the Marketing Department (10:11)
Product Management (7:35)
The Basics of Sales Forces (12:28)
3. Clinical Research
Clinical trials, CRA’s, and CRO’s (12:38)
Roles in Clinical Trials (12:27)
Quiz 2
4. Design Controls 101
Design Controls Part 1: DHF, Proposal, DDP, Inputs, Outputs, Specifications (16:09)
Design Controls Part 2: Design Verification (9:25)
Design Controls Part 2: Design Validation (9:32)
Design Controls Part 2: Design Transfer, Review, and Change (8:21)
Design Controls Document Templates - PDF
Design Controls Document Template - DDP
Design Controls Document Template - DID
Design Controls Document Template - DSD
Quiz 3
5. Risk Analysis for Medical Devices
Risk Analysis: FMECA, Risk analysis document (11:57)
Risk Analysis Document Template - Risk Analysis Instructions
Risk Analysis Document Template - Risk Analysis Template
Quiz 4
6. Organization Development in Device Companies
Organization types, putting together project teams (10:03)
Project Management vs. Design Controls (5:07)
Quiz 5
7. Consultants and Some Legal Basics
Consultants – Role in medical device development, Anti - kickback statute (14:31)
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Final quiz
Final graded quiz
Design Controls Part 2: Design Validation
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