MPD ISO 13485:2016 Appreciation and Interpretation Training

28 June 2016 MTIC, 4 Greenfield Crescent, Birmingham B15 3BE

Medilink West Midlands, in conjunction with LRQA are able to offer a discounted one day ISO 13485:2016 training course (standard LRQA price: £505 + VAT). This course is designed to give an insight into the development, implementation and management of a QMS based on ISO 13485. The experts at LRQA will offer an overview and an understanding of the intent and the requirements for ISO 13485:2016 quality management systems (QMS) and delegates will explore ISO 13485:2016 compatibility with other management systems and how to convert from ISO 9001 to ISO 13485:2016.

This course would be relevant for those within the following roles:

  • Quality Managers and personnel
  • Regulatory Affairs Managers and personnel
  • Anyone involved with the implementation of the standard.

By attending this course you will learn:

  • The scope and application of the ISO 13485:2016 standard
  • The differences between ISO 13485:2003, EN ISO 13485:2012 and ISO 13485:2016
  • Essential definitions and terminology to help you interpret and apply ISO 13485:2016 requirements
  • The key requirements of ISO 13485:2016 and how they relate to each other to form a robust effective system
  • How ISO 13485 forms the basis of worldwide Medical Device Regulation with particular emphasis on Canadian  Regulation CMDCAS
  • The relationship and differences between ISO 13485:2016 and ISO 9001:2015 requirements
  • The relationship between ISO 13485:2016 and the risk management standard ISO 14971.

Delegate fees

  • Medilink West Midlands member fee: £250
  • Medilink West Midlands non-member fee: £350

To register or for more information, please contact Sarah Wootton on 0121 452 5630.