Medical Device Regulations

Learn about the medical device industry and how to bring new products to market 510K, PMA, De Novo, ISO13485 and beyond!

What you'll learn
Learn how medical devices go from idea to product
Understand the 510K and PMA submission process for medical devices
FDA regulatory pathways including 510K, PMA, De Novo, IDE, HDE
Risk management and quality in device development
Learn how to research new devices and companies
Understand medical device career paths and opportunities

Requirements
No prior knowledge of medical device development is required
Knowledge of basic business practices and project management will be helpful but is not essential

Description
The medical device industry is growing rapidly, providing great opportunities for innovators, experts and entrepreneurs. This course will provide a detailed overview of the way in which new devices go from concept to product, providing you with a starting point to develop a deep understanding of this complex and fast-moving business space. We will cover all of the key components of bringing a new device to market, including:Paths to Market, including the 510K, PMA, HDE and other commonly used pathwaysClinical trials of medical devices, including IDE, submissions, records and reportingRisk management and quality in device developmentDuring this course we will also cover the publicly available information sources that will enable you to research device companies and understand their value. We will cover medical device databases that allow you to research marketed medical devices. We will cover clinical trial databases that allow you to research planned and ongoing trials of medical devices. Links to these freely available resources will be provided.This course will be a valuable resource for anyone interested in developing their basic knowledge of the medical device industry. For students and recent graduates in medical device engineering, this course will help you develop a knowledge of the industry and the regulatory steps that companies use to bring new innovations to market. For project managers, this course can help you to learn about this industry and equip you to manage medical device development projects. For professionals working in related fields, this course will provide an overview of the medical device industry.

Who this course is for:
Aspiring regulatory affairs specialists, project managers, subject matter experts and consultants, Entrepreneurs planning to bring a new medical device to market and need to know how to get started, Project managers interested in developing their knowledge of medical device projects, Graduate or undergraduate students wishing to deepen their knowledge of medical devices, Recently graduated engineers wishing to pursue a career in medical devices