Construction of a Technical File in line with 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.

It is the policy of SGS to deliver efficient, practical and thorough training and to provide accurate and current information to allow medical device manufacturers meet the global regulatory, quality and technical requirements for medical devices. This allows manufacturers to place products on the market with confidence and in the minimum time. 

The objective of this course is to familiarise delegates with the technical documentation requirements of the Medical Device Regulation 2017/745. Upon completion of this course, delegates will be able to:

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

Quality and regulatory professionals, engineers, supervisors and management. Delegates are expected to have a working knowledge of the ISO 13485 Standard, and the Medical Device Directive 93/42/EEC including 2007/47 amendment.