Course Aim

The aim of the Medical Devices e-Learning Bundle is to provide participants with a comprehensive understanding of the importance, implications, and specific requirements of ISO 13485:2016 and ISO 14971:2019. This bundle is designed to empower professionals with the knowledge and practical skills needed to effectively interpret, implement, and manage quality managements systems for Medical Devices, managing associated risks through interactive modules. Furthermore, participants in this course will be able to navigate key international regulations that apply to medical devices.

Course Description

This e-learning bundle is tailored for professionals seeking a thorough understanding of the requirements set forth by ISO 13485:2016, ISO 14971:2019, and medical device regulations. Ideal for individuals involved in quality management systems for medical devices, this course provides detailed insights into the standards’ specific requirements, updating your management system to comply with the latest version of 13485, and facilitating successful implementation of the controls within your organization.

How will I benefit?

• Understand the key concepts, principles, and requirements of ISO 13485:2016 and ISO 14971:2019.
• Identify and manage risks and opportunities associated with medical device management.
• Manage medical device risk and drive continual improvement
• Demonstrate environmental commitment to clients, regulators, and the public.
• Understand how managing quality and responsibly accounting for risk is a key element of a medical device organization’s performance and the benefits of integrating your QMS with your organization’s overall strategy
• Support your organization in recognizing corporate social responsibility and governance initiatives as well as protect its brand and reputation

What will I learn?

By the end of this bundle, you will be proficient in the essential aspects of ISO 13485:2016, ISO 14971:2019, and the Medical Device Regulation.

Who should attend?

Medical device Managers, Compliance Officers, Internal Auditors, Consultant, Professionals involved in implementing or managing Medical Device quality management systems.

How will I learn?

This is an online, interactive eLearning course Bundle. Learning is self-study and you can progress at your own pace. You will have access to the courses for 12 months.

What will I gain?

On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

Prerequisites

There are no formal prerequisites, however it will be useful for delegates to read the standards before taking the course.

Modules

• ISO 13485:2016 Awareness On-demand Module
• ISO 13485:2016 Fundamentals: Module 1
• ISO 13485:2016 Fundamentals: Module 2
• ISO 13485:2016 Fundamentals: Module 3
• ISO 13485:2016 Fundamentals: Module 4
• ISO 13485:2016 Fundamentals: Module 5
• ISO 13485:2016 Fundamentals: Module 6
• ISO 13485:2016 Fundamentals: Module 7
• ISO 14971:2019 Risk Management for Medical Devices: Module 1
• ISO 14971:2019 Risk Management for Medical Devices: Module 2
• ISO 14971:2019 Risk Management for Medical Devices: Module 3
• ISO 14971:2019 Risk Management for Medical Devices: Module 4
• ISO 14971:2019 Risk Management for Medical Devices: Module 5
• ISO 14971:2019 Risk Management for Medical Devices: Module 6
• ISO 14971:2019 Risk Management for Medical Devices: Module 7
• ISO 14971:2019 Risk Management for Medical Devices: Module 8
• ISO 14971:2019 Risk Management for Medical Devices: Module 9
• ISO 14971:2019 Risk Management for Medical Devices: Module 10
• Requirements for risk classification in the MDR: Module 1
• Requirements for risk classification in the MDR: Module 2