ISO 14971 Medical Device Development & Risk Management

Become a Medical device development and risk management expert inline with ISO 14971:2019

Created by: Robert Ryan
Founder of InnovEd Academy

What Will I Learn?

• By completing this course you will gain a comprehensive knowledge of medical device development and risk management per ISO 14971:2019
• Understand when and how to apply risk management through a the medical device lifecycle.
• Understand how to plan a medical device development.
• Gain a deep understanding of medical device design controls and systems engineering principles.
• Understand how ISO 14971 relates to other important international standards including IEC 60601, IEC 62304 and ISO 13485.
• Have a clear understand how to easily document design control and risk management activities.

Requirements

• While prior experience in medical devices or risk management is beneficial, the course is structured to provide foundational knowledge and advanced insights. Both beginners and experienced professionals will benefit from the material.

Target audience

• This course is designed for working professionals in the medical device industry, including (electronic, mechanical, system, firmware) engineers, software developers, firmware developers, data scientists, quality assurance specialists, regulatory affairs professionals, project managers, and others involved in medical device development and compliance.