A required part of conformity assessment and CE Marking is the need for technical documentation which includes the collation of supporting information about your medical device. Technical documentation is maintained throughout the product lifecycle. Learn how to assemble this and other types of required information so you can CE Mark your device in Europe.

Course Aim

This one-day 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

How will I benefit?

This course will help you to:

• 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?

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

• 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.

Course Duration

1 day

How will I learn?

Our unique accelerated approach fast-tracks learning, improves knowledge retention and ensures you acquire the skills to apply your knowledge straight away. This course involves practical activities, group discussions and classroom learning to help you develop a deeper understanding of the material and have a greater impact on job performance.

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

Detailed course notes provided.

Related Training

Requirements of the Medical Device Regulation (MDR) Training Course, Implementation of the Medical Device Regulation (MDR) for CE Marking Training Course and Medical Device Directive (MDD) to Medical Device Regulation (MDR) Transition Training Course.

Course Materials

Soft Copy: 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.

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 have their own copy. Soft copies of the digital loaner standard cannot be printed or downloaded.

Course Logistics

If your class is Live Online:

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

If your class is In-person :

• You are encouraged to bring a laptop with you to class.
• Please bring a picture ID such as a driver's license, passport, or work badge to class for verification purposes.

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