Medical Device: Roadmap to Market (Introduction to Regulatory Requirements

When designing and developing new medical devices, understanding the regulatory requirements is essential in determining the pathway to commercialisation.

This course will provide an overview of the global regulatory environment for medical devices, the different pathways to market, and how to design a medical device in line with these regulations and international standards.

You will learn how to compile an effective regulatory strategy for new devices, understand what are intended use statements and why they are important and how to apply the classification rules for new devices.

• The Global regulatory landscape for medical devices
• What is the Intended Use statement and why is it important
• Classification rules for medical devices
• How the GSPR checklists/Essential Principles checklists drive medical device design and development
• ISO 14971:2019 – the role of risk management in design and development of medical devices
• Summary of Quality Management Systems; ISO 13485:2016, 21 CFR Part 820, MDR and IVDR
• International standards, normative references and ‘State of the art'
• Project management for design and development of medical devices
• Designing a medical device in line with regulatory and international standards
• How to compile a Technical File (Europe, USA, Australia)
• How to compile a regulatory strategy