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Publication of the Medical Device International Standard, ISO 13485

ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes, the internationally recognized medical device industry quality management systems (QMS) standard, has been under revision since 2010. The published standard was available on 25 February 2016, and this webinar will introduce you to the final standard and guide you through the BSI transition plans.

BSI, the UK National Standards Body has participated by providing technical input and commentary throughout the full standard development.

The new ISO 13485 will be applicable across the whole supply chain and will seek to address the entire lifecycle of a medical device. Some of the key changes, anticipated include:

  • Harmonization of regulatory requirements
  • Inclusion of risk management throughout the QMS
  • Additional clarity with regard to validation, verification, and design activities
  • Strengthening of supplier control processes
  • Increased focus regarding feedback mechanisms
  • Software for QMS, manufacturing and the medical device

The webinar will highlight the actions you should be taking now and how to plan for the implementation of the standard following publication.

Presenters

Vicky Medley is Head of QMS at BSI Medical Devices and has worked within the Medical Device industry for 19 years and is currently responsible for BSI's Quality Management System assessments that support BSI certification for CE Marking, ISO 13485 and related medical device schemes globally.

Linda Moon is an IVD Product Specialist in Healthcare at BSI. Her key roles are assessing clients to ISO13485, CMDCAS, IVD and MDD quality systems management and ISO9001 and delivering training courses: predominantly ISO13485, internal auditor and the IVD courses.