Medical Devices Regulation (MDR) Transition Training Course (EU) 2017/745
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Course Overview
What you'll learn
This course will help you to understand:
- Understand the technical documentation requirements of the Medical Device Regulation (MDR) 2017/745
- Understand what Notified Bodies are looking for, when Technical Documentations are assessed
- Understand why Technical Documentations need to be “live” documents and cover full product life cycle
- Updating your MDD technical documentation to an MDR compliant one
- Appreciate the role of guidance documents
Who This Course Is For
This training course is for:
- Regulatory personnel
- Managers
- CEOs
- CFOs
- IVD device industry employees
- IVD device users
- Anyone who wants to learn about the new regulations
About this course
Understand the additional requirements of the Medical Device Regulation (MDR), including the current directives MDD 93/42/EE and ISO 13485:2016, terminology and certification requirements. The new European MDR rules will apply after a transition period of three years. To help medical device manufacturers understand the additional requirements of the standard, we have developed the MDR Implementation Training Course (EU) 2017/745.