Introduction to ISO 13485:2016 Quality Standard for the Medical Device Industry

Gain an understanding of the role of quality standards for the medical device industry within your organisation on our Introduction to ISO 13485 for Medical Devices training course.

This 1-day practical course provides a basic background to the structure and requirements of ISO 13485 and how it relates to frameworks such as the Medical Device Regulations (MDR). Students benefit from interactive sessions where they can develop the knowledge they gain.

Upon completion of the course, delegates will have the skills to review their organisation’s current processes and systems, understand the benefits and challenges of a process approach to managing a quality management system, and consider how to implement ISO 13485 within their organisation.

This course is suitable for anyone seeking a detailed overview of ISO 13485 and the process approach to managing a company’s quality system, including:

  • executives and senior management
  • general managers and business unit managers
  • quality and regulatory professionals
  • management representatives
  • internal and external auditors

This course is the ideal introduction for those who are planning to attend our ISO 13485 Internal Auditor training course but first need to develop their understanding of ISO 13485. We can offer a discount of £100 to those who book both courses at the same time.

Topics covered on the course include:

  • the purpose and intent of ISO 13485
  • the origins of the standard and the different versions, including latest ISO 13485:2016+A11 2021
  • structure and content of the standard and the PDCA cycle
  • key terms and definitions
  • how the standard supports medical devices regulations and an overview of:
    • UK Medical Device Regulations 2002
    • European Medical Device Regulations 2017
    • USA Food and Drug Administration quality system requirements
    • Medical Devices Single Audit Programme
  • the process approach and process-related requirements of ISO 13485
  • requirement for documenting the QMS and maintaining records
  • overview of all of the ‘auditable’ requirements of ISO 13485, sections 4-8, with in-depth coverage of key requirements
  • technique for conducting an in-depth analysis of the requirements
  • an approach to implementing an ISO 13485 QMS

By the end of this ISO 13485 training course, delegates will be able to:

  • explain the purpose, structure and content of ISO 13485
  • define key terminology from ISO 13485
  • identify key medical devices regulations and explain their relationship with ISO 13485, including:
    • EU MDR
    • UK MDR
    • USA FDA
    • MD SAP
  • analyse and apply ISO 13485 requirements
  • outline steps for implementing an ISO 13485 QMS

You can schedule the Introduction to ISO 13485:2016 for Medical Devices training course to take place at your offices, a venue of your choice or online on your preferred date. This may be a suitably convenient and cost-effective choice if you have several team members to train.

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