We provide online course about MDR and ISO 13485 for subcontractors in english. The MDR requirements for manufacturers have increased, and manufacturers have to take responsibility for controlling their subcontractors.
Content:
What are the consequences for the manufacturer? And what does this mean in practice for the subcontractors? What are the expectations for the subcontractors’ quality management system, their documentation, their subcontractors? When should the subcontractors' name and address be entered on the product and in the EUDAMED database?
Upon successful completion of the course, you will be able to understand the MDR requirements of the companies that are suppliers to medical device manufacturers (Articles 10 to 20 and Annexes I to IV and IX). You will then, in an effective way, be able to plan and evaluate the implementation of the MDR requirements in your own company.
Topics:
In this module you will learn which document requirements a subcontractor should focus on:
• The requirements of EN ISO 13485:2016
• MDR requirements (Articles 10 to 20, Annexes I, II, III, IV and IX)
• 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 subcontractors to the medical device industry who want to understand what is relevant for them in the MDR, as well as for manufacturer who need to manage their suppliers. The content is relevant to manufacturers, distributors, EU representants, importers and subcontractors.