We provide online course about MDR, ISO 13485 and the technical documentation in english. The classification of medical devices has been changed to a higher class for some medical devices. It places new demands on manufacturers and their product documentation.
Content:
Manufacturers were given one more year to prepare for the MDR with a deadline of 26 May 2021. Manufacturers of Class 1 medical devices that are to be converted to a higher class have up to 2024 to obtain the certification with a notified body. Upon successful completion of this course, you will understand the MDR requirements for the technical documentation (Annexes VIII, I, II, IV and V) as well as the requirements for manufacturers (Article 10 and Annex X Chapter I). You will then understand how to build a technical documentation for medical devices.
Agenda:
In this module you will learn how to build a technical documentation for medical devices. You will get insight into how the manufacturer should handle CE marking, and the approach to use to meet the various requirements and deadlines. Finally, you will see how to ensure optimal cooperation with your partners with the common purpose of collecting all relevant documents for the technical documentation.
Topics:
You will see how to use your company’s quality management system to systematically collect the product documentation:
• The EN ISO 13485:2016 standard
• MDR product requirements for CE marking (Annex I to VI and VIII)
• Synergy between ISO 13485 and MDR product requirements
• Interpretation of the requirements in relation to the company's own terms and strategic direction
• You will be able to practice in the process during exercises and ask questions throughout the course
The course is offered by: Bureau Veritas Certification Denmark A/S
Information:
In preparation for the course, Bureau Veritas submits material on legal requirements and quality management. This must be reviewed and understood before the course starts. You should expect approx. 1 day preparation.
Target group:
This course provides a good boost of competences for everyone who work with technical documentation of medical devices under the MDR requirements. The content of this coruse is relevant for manufacturers, distributors, EU representant, importer and subcontractors.