Requirements of the Medical Device Regulation (MDR)

On-demand eLearning Course

Requirements of the Medical Device Regulation (MDR)

Level ข้อกำหนด ระยะเวลา 5 hours

จองการฝึกอบรม:: On-demand elearning ฿4000 จองการฝึกอบรม

This on-demand course will give you an understanding of the key requirements, which will provide:

Essential knowledge to understand Regulatory Affairs of medical devices in the EU, e.g. in the position of top management, or a manager or project member in QM/QA, R&D, design, manufacturing, supply chain, customer service and sales
The ability to understand the demands of the subcontractor, supplier, OEM, authorized representative, importer, distributor, allowing better relationships between them and the legal manufacturer
A basis to learn later about implementation of CE marking projects

How will I benefit?

This course will help you:

Understand the key requirements and concepts of the European Medical Devices Regulation
Communicate the impact of the key requirements introduced by the MDR to your organization

By the end of the course, you’ll be able to:
- Communicate the key requirements and concepts within the Regulation
- Reference the necessary aspects to evaluate if and how your company is affected by MDR and to what extent
- Define the vocabulary used within the MDR
- Explain the structure and administration of the Regulation
- Recognize partners of manufacturers affected by the Regulation
- Describe the key steps of a conformity assessment
- Explain the main impacts on the quality management system (QMS) relating to MDR
- Recognize the requirements for post-market surveillance and updates
The course is especially suitable for:
- New starters in Regulatory Affairs (RA) and those increasing their responsibility in this area, and RA professionals who are not familiar with the European MDR
- Anyone working with Regulatory Affairs departments, e.g. top management, manager or project member in QM/QA, R&D, design, manufacturing, supply chain, customer service and sales
- Staff working for organizations that partner with Medical Device manufacturers, e.g. as subcontractor, supplier, OEM, authorized representative, importer, distributor, auditee etc.
Please note: This course will not cover In Vitro Diagnostic Devices. Please refer to the ‘Related training’ below if you need more detailed information e.g. for implementation.
- นี่คือหลักสูตร eLearning
- ภาษาที่ใช้ในการอบรม : ภาษาอังกฤษ (English)
- ระยะเวลาในการเข้าถึงหลักสูตร : 12 เดือน
- ผู้เข้าอบรมจะได้รับใบประกาศนียบัตรรับรองของ BSI Training Academy หลังเสร็จสิ้นการฝึกอบรม

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