EU MDR & EU IVDR
European Union Medical Device Regulation – EU MDR
European Union In Vitro Diagnostic Device Regulation – EU IVDR
Post Market Surveillance and Vigilance Requirements for Manufacturers (EU 2017/745)

US FDA Regulations
US Medical Device Regulations – A Comprehensive Overview
US FDA Medical Device Reporting Requirements
US FDA Pre-submission (Q-Sub) Program – Requesting FDA Feedback
US FDA Medical Device Complaint Handling and Servicing – Plus ISO 13485:2016 Requirements
US Quality Systems & Combination Products – Practical Application
510K Changes Guidance – Deciding When to Submit a new 510(k) for Existing Devices
Data Integrity: Overview and Documentation Completion, Review and Approval

International Standards and Programs
ISO 13485:2016 – International Medical Device Quality Management System (QMS) Standard
ISO 14971:2019 – Application of Risk Management to Medical Devices

MDSAP

MDSAP and Regulatory Transitions – The Basics Virtual Training
Medical Device Country-Specific Regulatory Requirements (5 course bundle – MDSAP participating counties)

Country-Specific Medical Device Regulations
Australia Medical Device Regulations – A Comprehensive Overview
Brazil Medical Device Regulations – A Comprehensive Overview
Canada Medical Device Regulations – A Comprehensive Overview
Japan Medical Device Regulations – A Comprehensive Overview
United States Medical Device Regulations – A Comprehensive Overview
China Medical Device Regulations – A Comprehensive Overview

Global Quality Systems Requirements
US Quality Systems & Combination Products – Practical Application
Design Controls for Medical Devices and IVDs
US FDA Medical Device Complaint Handling and Servicing – Plus ISO 13485:2016 Requirements
Data Integrity: Overview and Documentation Completion, Review and Approval