Webinar: MDR – Quality Management System Requirements
Join us to gain insights from our experts and learn how to overcome common challenges in QMS implementation and MDR compliance.
Navigating the complexities of the medical device regulatory landscape can be challenging. With the introduction of Regulation (EU) 2017/745, Article 10, medical device manufacturers are now required to meet new standards for their Quality Management System (QMS).
To help you understand these changes and ensure your QMS is robust and compliant, we are hosting a webinar that will provide a deep dive into the specific requirements of EU-MDR and in compare with ISO 13485. Our experts will also address challenges commonly encountered during QMS implementation and compliance with the MDR.
Webinar highlights:
- CE Certification – Conformity assessment procedures
- Quality Management System (QMS) Requirements
- Specific requirements for QA/ EUDAMED/ GSPR/ PMS & Vigilance/ PRRC/ UDI/ Change Notifications/ Production/ Design & development/ Purchase/ etc.
- ISO 13485 vs MDR-QMS
- How DNV could support medical device manufacturers
- Q&A Session
We will be offering the webinar in two different sessions at your convenience:
Option 1:
Date: Tuesday, 23 April 2024
Time: 14:00PM AEST
Registration Link: Click here
Option 2:
Date: Tuesday, 23 April 2024
Time: 15:00PM IST
Registration Link: Click here
Presenter:
Hasan Zarin Mehr
Senior Lead Auditor, Supply Chain & Product Assurance
DNV Australia
We look forward to your participation!
Navigating the complexities of the medical device regulatory landscape can be challenging. With the introduction of Regulation (EU) 2017/745, Article 10, medical device manufacturers are now required to meet new standards for their Quality Management System (QMS).
To help you understand these changes and ensure your QMS is robust and compliant, we are hosting a webinar that will provide a deep dive into the specific requirements of EU-MDR and in compare with ISO 13485. Our experts will also address challenges commonly encountered during QMS implementation and compliance with the MDR.
Webinar highlights:
- CE Certification – Conformity assessment procedures
- Quality Management System (QMS) Requirements
- Specific requirements for QA/ EUDAMED/ GSPR/ PMS & Vigilance/ PRRC/ UDI/ Change Notifications/ Production/ Design & development/ Purchase/ etc.
- ISO 13485 vs MDR-QMS
- How DNV could support medical device manufacturers
- Q&A Session
We will be offering the webinar in two different sessions at your convenience:
Option 1:
Date: Tuesday, 23 April 2024
Time: 14:00PM AEST
Registration Link: Click here
Option 2:
Date: Tuesday, 23 April 2024
Time: 15:00PM IST
Registration Link: Click here
Presenter:
Hasan Zarin Mehr
Senior Lead Auditor, Supply Chain & Product Assurance
DNV Australia
We look forward to your participation!