The Medical Devices Regulation (MDR) is the legislation detailing the requirements that manufacturers must meet to place medical devices on the market in the European Union.
Learn some key requirements about Annex VII of the MDR and gain a better understanding of why notified bodies may be seen to behave differently and in a much more detailed way than what organisations may have previously experienced.
On-demand - training that’s even more flexible
This short mini course aims to provide some insight into one of the key annexes in the Medical Device Regulation (MDR) – Annex VII. Manufacturers may not be so familiar with this particular annex as the requirements are mainly aimed at Notified Bodies. This course also links some of the clinical evaluation requirements from the MDR.
How will I benefit?
This course will help you:
- Appreciate the requirements of Annex VII from the MDR
- Gain a better understanding of some key Notified Body requirements within the MDR
Who should attend?
Quality, Regulatory, Technical professionals working in the Medical Device industry
What will I learn?
By the end of the course, you will be able to:
- Establish the requirements detailed in Annex VII of the MDR
- Appreciate the Notified Body prospective and approach when assessing against the MDR
- Gain an overview of the clinical evaluation requirements
- Understand audit duration and approach of Notified bodies as per the MDR
What is included?
- นี่คือหลักสูตร eLearning
- ภาษาที่ใช้ในการอบรม : ภาษาอังกฤษ (English)
- ระยะเวลาในการเข้าถึงหลักสูตร : 12 เดือน
- ผู้เข้าอบรมจะได้รับใบประกาศนียบัตรรับรองของ BSI Training Academy หลังเสร็จสิ้นการฝึกอบรม
