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Understand the technical documentation requirements of the Medical Device Regulation 2017/745.

This course is designed to familiarise quality and regulatory professionals, engineers, supervisors and management with the technical documentation requirements of the Medical Device Regulation 2017/745.

Why choose the Medical Device Regulation 2017/745 – Technical Documentation course from SGS?

This course will enable you to:

  • Understand the technical documentation requirements of Medical Device Regulation 2017/745 and how to interpret them
  • Prepare technical documentation to meet the requirements of the Medical Device Regulation 2017/745
  • Use the references and guidance documents available to further enhance your understanding of the documentation requirements

Prior knowledge

To take this course, you will need a working knowledge of the ISO 13485 Standard, and the Medical Device Directive 93/42/EEC Inc. 2007/47 amendment.

Course content

This course covers:

  • The general requirements, including description, intended use, medicinal substances, animal tissue, classification, links to other directives and declaration of conformity
  • Manufacturing specifications
  • General safety and performance requirements
  • PMS/PMCF

Course details

Course duration: 1 day
Delivery methodology: face to face
Course language: English

The trusted Medical Device Regulation 2017/745 technical documentation training course from a world leader in corporate training

As the world leader in professional training, we offer you unrivalled experience and a global network of qualified professionals with extensive expertise in the latest practices. SGS Academy is present in more than 45 countries and trains more than 200,000 professionals worldwide.

To find out more about our Medical Device Regulation 2017/745 – Technical Documentation training course, or to book your training, contact us today.