We provide online course about MDR, ISO 13485 and the post marketing feedback Requirements in english. MDR requirements for the technical documentation have been tightened up. The technical documentation is a prerequisite for the CE marking of medical devices.
Content:
Those MDR requirements can be found in Annexes I to III. The technical file is a living document. Changes in the technical file can be initiated by sales with new versions of the device, quality for improvements, customer complaints or internal / external audits. Changes reflect the company’s development and focuses. Changes shall be controlled and clearly documented through the company’s quality management system.
Upon successful completion of the course, you will be able to understand the MDR requirements for the technical documentation for medical devices (Appendices I, II, III). The change process and the collaboration between sales, development, production, quality and regulatory affairs will be outlined. You will then, in an effective manner, be able to plan and evaluate the implementation of the requirements in your own company.
Agenda:
At this course you will learn how your company shall build and maintain the technical documentation based upon the feedback activities, how the roles are distributed, who is responsible, and where input shall be collected. You will gain knowledge of the various product documentation that a company must focus on in the technical documentation:
Topics:
• The requirements of the EN ISO 13485:2016 standard
• MDR requirements (Annexes I, II, III)
• Collection of feedback and integration into the QMS
• Interpretation of 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 are involved in the technical documentation of medical devices under the MDR requirements: quality, regulatory affairs, intern auditor. The content is relevant to manufacturers, distributors, EU representants, importers and subcontractors.