We provide online course about MDR, ISO 13485 and quality management system requirements in english. The Medical Device Regulation (MDR) set requirements for the manufacturer´s quality management system (QMS) as well as for the products.
Content:
According to MDR, the quality management system shall ensure that the production and distribution of medical devices take place in a safe manner. Manufacturers of medical devices shall implement a quality management system according to Article 10 chapter 9 requirements. Annex IX Chapter 1 of the MDR describes practical requirements for the quality management system.
Upon successful completion of this course, you will be able to understand the MDR requirements of Article 10 chapter 9, and how Annex IX Chapter I can be used by auditors, manufacturers, distributors, service providers and suppliers of medical devices. You will then, in an effective way, be able to plan and evaluate implementation of the requirements in your own company.
Agenda:
This course presents the general QMS structure with a focus on risks around processes in accordance with the MDR requirements. Correlation between requirements in MDR and ISO 13485 will also be presented, as well as how to use your ISO 13485 certification to fulfill the MDR requirements.
Topics:
This course presents the various quality management aspects a company must focus on:
• The EN ISO 13485:2016 standard
• MDR requirements for the quality management system
• 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:
The content of this course is relevant for manufacturers, internal auditors, quality assurance managers and employees, regulatory affairs managers and employees, managers in a medical device manufacturing company, distributors, and subcontractors. The course provides a good boost of competence for everyone who is involved in the implementation and maintenance of the MDR requirements.