Course aim

This intensive course enables greater understanding of the key requirements for technical documentation for medical devices, in line with the European Medical Device Regulation (MDR) requirements in Europe. The aim of the course is to enable manufacturers to:

• Create robust technical documentation to demonstrate compliance to the MDR
• Better understand regulatory requirements and Notified Body expectation, to prevent unnecessary delays to the certification process

Course description

BSI’s on-demand courses are market-leading and available 24/7. Developed by top subject matter experts, they contain the same high-quality content you will find in our tutor-led training, but with the added benefit of being able to learn at your own pace and at any time.

How will I benefit?

This course will help you:

• Ensure auditable technical documentation meets regulatory requirements and demonstrates product safety and performance
• Reduce delays to product certification by providing complete and compliant documentation
• Reduce costs by reducing audit questions and nonconformities, thereby streamlining the certification process

What will I learn?

You will learn about:

• Confirm the technical documentation requirements as specified in the MDR and relevant guidance documentation
• Interpret the MDR in relation to the technical documentation requirements
• Define the process enabling the creation and maintenance of compliant technical documentation
• Grasp how standards and guidance can be used to improve your technical documentation
• Recognize what is expected by Notified Bodies for technical documentation during reviews and be better prepared
• Recognize the documentation requirements during the product lifecycle and the post-market updates needed

Who should attend?

QA/Regulatory personnel involved in compiling technical documentation; product design personnel and those in research and development for medical devices intended for the European market.

How will I learn?

This is an online, interactive on-demand course. 

Courses are available 24/7 and you can learn at any time and from any place that suits you – you just need an internet connection.

You can learn as fast or as slowly as you want to. You can also take breaks at any time in the course and pick up where you left off when you are ready to continue.

During the access period, you can go back and repeat parts or all the course to refresh and reinforce what you have learned.

The course content is both detailed and engaging, with explanations, activities, and knowledge checks to enhance your learning.

What will I gain?

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

Prerequisites

You should have a basic understanding of European Medical Device Regulation (MDR).

Further information

Benefits of On-Demand for the individual:

• Convenient - Courses are available 24/7 and you can learn at any time and from any place that suits you – you just need an internet connection
• Learning pace - You can learn as fast or as slowly as you want to. You can also take breaks at any time in the course and pick up where you left off when you are ready to continue
• Information retention - During the access period, you can go back and repeat parts or all the course to refresh and reinforce what you have learned
• High-quality materials - Developed by top subject matter experts, course content is both detailed and engaging, with explanations, activities, and knowledge checks to enhance your learning

Delegates completing the course will be issued an attendance certificate. By taking and passing the optional end-of-course exam, delegates will be issued with a further certificate of achievement.

Modules

• Module 1: Technical Documentation and Conformity Assessment for Medical Devices
• Module 2: Importance of Technical Documentation
• Module 3: Design and Manufacturing Information for Technical Documentation
• Module 4: Verification and Validation
• Module 5: Post-market Surveillance (PMS) and Clinical Evaluations
• Module 6: Declaration of Conformity and Summary of the Documentation Required