Single Course Medical Devices

Medical Devices Regulation (MDR) Transition Training Course (EU) 2017/745

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2 days Virtual Class English Identifier: 51099582
Medical Devices Regulation (MDR) Transition Training Course (EU) 2017/745

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.

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