A required part of conformity assessment and CE Marking is the need for Technical Documentation which includes the collation of supporting information about your IVD Device. Technical documentation is maintained throughout the product lifecycle. Learn how to assemble this and other types of required information so you can CE Mark your device in Europe.
How will I benefit?
This course will help you learn:
- Technical documentation requirements under the European IVD Regulation
- Be able to review technical files and be able to create new files to support IVD products
- How standards and guidance can be used to improve technical documentation
Expectations of Notified Bodies for technical file
Who should attend?
QA/Regulatory personnel involved in compiling technical documentation and design dossiers. Product design personnel and those in Research & Development for IVDs intended for the European market.
How will I learn?
Our on-demand courses allow learners access to knowledge-based content in real time, anywhere, and at anytime. Using established learning and interactive digital technology, on-line attendees are guided through the course content, at their own pace, providing opportunity to review, test knowledge and confirm understanding, as they progress through the course.
What is included?
- นี่คือหลักสูตร eLearning (ราคายังไม่รวม Vat 7%)
- ภาษาที่ใช้ในการอบรม : ภาษาอังกฤษ (English)
- ระยะเวลาในการเข้าถึงหลักสูตร : 12 เดือน
- ผู้เข้าอบรมจะได้รับใบประกาศนียบัตรรับรองของ BSI Training Academy หลังเสร็จสิ้นการฝึกอบรม
Prerequisites
You should have a basic understanding of European IVD device regulations.
