BSI Connected Learning Live is a live, online training that combines premier skills development technologies with our expert instructors to deliver an engaging, interactive learning experience to you, regardless of location.

This course is designed to provide you with an understanding of ISO 14971:2019 and the impact it has on the design, development, manufacturing and lifecycle of medical devices. It will also provide medical device manufacturers with knowledge of how ISO 14971:2019 links with the ISO 13485:2016 standard and the MDR 2017/745. Practical activities throughout the day will give you the opportunity to apply your skills, implementing risk management activities so that these can be embedded within the organization on completion of the course.

Learning Objectives

Upon Completion of this training, you will be able to:

• Define risk management terminology
• Explain how risk management relates to the product lifecycle
• Outline the stages of the risk management process
• Define the key deliverables of the risk management process
• Apply risk management principles within your organization
• Identify the links between ISO 14971:2019, ISO 13485:2016, MDR 2017/745 and the IVDR 2017/746

Course Materials

You will receive an email prior to the course with instructions on how to access the online Student Handbook, which can be viewed, downloaded or printed, will be sent to students.

NOTE: Copies of the standards are not included in the class fee. BSI will make reasonable efforts to have loaner copies available for use during the class, but students are encouraged to bring their own copy. Soft copies of the digital loaner standard cannot be printed or downloaded.

Who Should Attend?

This course is ideal for you if you’re in a QA/Regulatory/Engineering/Manufacturing role involved in medical device design, development and manufacturing.

Course Logistics:

• Students need to connect to the class from any internet accessible location
• Webcam and Headset with Microphone are REQUIRED
• ALL courses times shown are US EASTERN TIME

There are two 4 hour sessions*, one per day.

*Session lengths could vary depending on amount of class discussion.