Design Controls – Part 1 – Design History File

Course Outline

Module 1	Design Controls for Medical Devices Forum
Unit 1	Forums - Design Controls for Medical Devices
Module 2	Design Controls - 21CFR 820 / ISO 13485:2016
Unit 1	Introduction to Design Controls
Unit 2	Design Controls - Part 1 - Planning, Input, Output
Unit 3	Design Controls - Part 2 - Design Verification / Validation, Design Review, Design Change
Module 3	Design Controls Documents
Unit 1	Design Controls Document - The Project Definition Form
Unit 2	Design Controls Document Examples

Medical Device Courses