Fundamentals Of Medical Devices

Introduction to Medical Devices &IVDs

What you'll learn
Different definitions of Medical Devices and In-Vitro Diagnostics IVDs
Classifications of Medical Devices and In-Vitro Diagnostics IVDs
Regulations of Medical Devices and IVDs
Quality Management System

Requirements
This course is for beginners in regulatory affairs of medical devices and who wish to know the basics behind the medical devices
Scientific background is required but not mandatory

Description
This course offers a comprehensive introduction to the regulatory landscape for medical devices. It covers essential topics such as device classification, regulatory frameworks, clinical evaluation, quality management systems, and post-market surveillance. Participants will gain practical insights into the key regulatory requirements and processes necessary for compliance in major global markets.Who Should Attend?This course is ideal for:- New professionals in the medical device industry.- Regulatory affairs professionals transitioning from other industries.- Quality assurance and compliance personnel.- R&D engineers and project managers.- Healthcare professionals interested in regulatory aspects of medical devices.- Anyone seeking a foundational understanding of medical device regulations.Learning Outcomes:By the end of this course, participants will be able to:1. Understand the regulatory classification of medical devices.2. Navigate key global regulatory frameworks, including EU MDR and FDA regulations.3. Develop and maintain technical documentation and quality management systems.4. Prepare for regulatory submissions and market access.Outlines:1. Introduction to Medical Devices- Definition and examples- Device vs. pharmaceuticals2. Regulatory Frameworks- Overview of global regulations- Key regulatory authorities3. Device Classification- Classification criteria and examples- Risk-based classification4. Conformity Assessment and CE Marking- Notified Bodies and their roles- Steps to obtain CE marking5. Technical Documentation- Essential components- Preparing a technical file6. Quality Management Systems (QMS)- ISO 13485 overview- QMS implementation7. Regulatory Submissions and Approvals- Submission processes for major markets- Interactions with regulatory authorities