Advanced Medical Device Development Course

Module 1	Course
Unit 1	Forums - Advanced Medical Device Development
Module 2	Introduction to Advanced Medical Device Development
Unit 1	Introduction to Advanced Medical Device Development
Module 3	EU Regulatory Basics
Unit 1	EU Regulatory Basics - EU Regulatory Intro
Unit 2	EU Regulatory Basics - EU Government Structure and Legislation Process
Unit 3	EU Regulatory Basics - Medical Device Directives
Unit 4	EU Regulatory Basics - Tech File and Design Dossier
Unit 5	EU Regulatory Basics - MDD/AIMDD/IVDD Documentation The New MDR and IVDR Changes
Unit 6	EU Regulatory Resources
Module 4	The Design History File - In depth
Unit 1	Design History File (DHF) Basics
Unit 2	Design Specification Document & Design Matrix
Unit 3	Verification and Validation (V&V)
Unit 4	Design and Process Documents
Module 5	Device Documentation: DHR, DMR, SOP's, ECO
Unit 1	The Device Master Record
Unit 2	The Device History Record
Unit 3	SOP's and ECO's
Unit 4	Design and Process Documents 2
Module 6	Process Validation and Process Risk
Unit 1	Process Validation Introduction
Unit 2	Process Validation: To Validate, or Not to Validate
Unit 3	IQ/OQ/PQ
Unit 4	Process Risk Analysis
Unit 5	Design and Process Documents 3
Module 7	Quality Systems Management
Unit 1	Introduction to Quality
Unit 2	How the QSR works
Unit 3	Applications of the QSR
Unit 4	Audit and Acceptance Processes
Unit 5	CAPA and Non-conformance
Unit 6	Quality System Documents
Module 8	Clinical Trials for Medical Devices
Unit 1	Foundations of Clinical Research
Unit 2	Informed Consent and Institutional Review Boards
Unit 3	Clinical Trial Roles and Responsibilities
Unit 4	Types of Clinical Trials
Unit 5	Clinical Research Documents
Module 9	The Product Life Cycle & Product Management
Unit 1	Introduction to the Product Life Cycle
Unit 2	Discovery & Innovation
Unit 3	Product Development & Post-Marketing