MPD ISO 13485 introduction and interpretation

23 February 2016 4 Greenfield Crescent, Edgbaston, Birmingham B15 3BE

Medilink West Midlands, in conjunction with LRQA, are able to offer a discounted one day ISO 13485 training course (standard LRQA price £505.00 + 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 be able to guide you through the key requirements for implementing ISO 13485 and explore the key definitions and terminology surrounding the standard. You will look at how ISO 13845 operates and its relationship with ISO 9001 and 14971.

You need this course if you want:

  • An overview and an understanding of the intent and requirements of ISO 13485 Medical Devices quality management systems (QMS)
  • To know which version of ISO 13485 you need to implement within your organisation
  • To understand ISO 13485 compatibility with other management systems
  • To convert from ISO 9001 to ISO 13485
  • To create a single quality system that meets global regulations.

Who should attend?

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

  • Quality managers and personnel
  • Regulatory affairs managers and personnel
  • Anyone involved with the implementation of the standard.

By attending this course, delegates will learn:

  • The scope and application of the ISO 13485 standard
  • The differences between ISO 13485:2003 and EN ISO 13485:2012
  • Essential definitions and terminology to help interpret and apply ISO 13485 requirements
  • The key requirements of ISO 13485 Medical Devices 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 and ISO 9001 requirements
  • The relationship between ISO 13485 and risk management standard ISO 14971 and ISO/TR 14969.

Delegate fees (delegate fee includes all course materials, refreshments and lunch)

  • Member fee: £250
  • Non-member fee: £350

For more information, please contact Sarah Wootton on 0121 452 5630 or SarahW@MedilinkWM.co.uk. To register, please visit the Medilink West Midlands website