Description

ISO 13485:2016 – Design and Development of Medical Devices

COURSE CONTENT

What delegates will learn in this course?

• Brief detail about ISO 13485:2016 standard.
• What is the “design and development” process of a medical device?
• What are the phases of “design and development” for a medical device?
• How to manage the “design and development” in a life-cycle of medical device?
• FDA Waterfall model for design and development
• Unique rising model for design and development developed as per ISO 13485

Self-Paced Course Description:

This is a self-paced course on the design and development of medical devices as per ISO 13485:2016 and best practices in the medical devices sector. ISO 13485:2016 is the recognized global standard for the quality management system (QMS) of medical devices manufacturers and suppliers. The standard name is also prescribed with the supporting expression “For Regulatory Purposes”. It means the standard is developed to assist organizations in complying with the regulatory requirements as well. The design and development process in a QMS is the most complex part. Likewise in the medical devices sector, design and development is a complicated process that incorporates numerous roles and phases. Therefore this course is designed to adapt the process of design and development of medical devices easier for delegates to learn. In this session, the rising model based on ISO 13485:2016 requirements of design and development is discussed. The rising model is developed by the Trainer himself and is, therefore, a unique way of explaining the ISO 13485 requirements on design and development. This is in contrast with the FDA waterfall model.

Who should take this self-paced course

• Employees in the field Quality Management who are new in medical devices sector.
• Any professional who is working or opts to work in the Research and Development of a company producing medical devices.
• Product development persons in medical devices industry.
• Medical engineers who opt to work in a this industry.
• Employees looking to learn ISO 13485:2016.
• Any individual who opts to work and make a career in the medical devices industry.

COURSE CONTENT