ISO 13485 Medical Device

by International Associates (IA) Claim Listing

The aim of this course is to provide delegates with the knowledge and skills required to perform an audit of part of a quality management system based on ISO 13485 and report on the effective implementation and maintenance of the management system in accordance with ISO 19011.

Price : Enquire Now

Contact the Institutes

Fill this form

Advertisement

International Associates (IA) Logo

img Duration

Please Enquire

Course Details

Course aims.

The aim of this course is to provide delegates with the knowledge and skills required to perform an audit of part of a quality management system based on ISO 13485 and report on the effective implementation and maintenance of the management system in accordance with ISO 19011.

What will I learn?

  • Interpretative skills in understanding the requirements of ISO 13485:2016

  • Effective auditing techniques

  • Practical knowledge of the Management System Approach

  • Application of methods and techniques to conduct, and generate findings, on an ISO 13485:2016 audit.

  • Core concepts and background on medical devices – Quality management systems in the supply chain.

  • Review of common compliance problems and possible solutions.

  • Application of methods and techniques to gather, evaluate & triangulate satisfactory objective evidence during an audit to determine the conformance of a system.

  • Ability to generate accurate, appropriate, and comprehensive audit findings and conclusions.

This course will teach students the principles of ISO 13485:2016 and how to use tools as well as to teach students how to apply methods and techniques to plan and conduct an ISO 13485:2016 Audit.

Is this course right for me?

This course is aimed at:

  • 3rd party ISO 9001 auditors converting to ISO 13485

  • Key personnel from organisations that are currently implementing a QMS

  • Managers and staff who are, or are about to become members of the organisation’s audit team

  • Quality Managers, Regulatory / Compliance Managers, Internal Auditors and Consultants.

  • Glasgow Branch

    38 Queen Street, Glasgow

Check out more ISO 13485 (Medical Devices) courses in UK

Educo Life Sciences Logo

Implementing ISO 13485:2016 and MDSAP

ISO 13485 quality management systems for medical devices and IVDs provide the framework to consistently produce safe and effective medical devices. The latest version has additions such as regulatory harmonisation and a greater emphasis on risk management. In addition, many countries have committed

by Educo Life Sciences [Claim Listing ]
Bywater Training Limited Logo

Introduction to ISO 13485 for Medical Devices

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.

by Bywater Training Limited [Claim Listing ]
HSEQ Smart Logo

ISO 13485 Medical Devices Management System

The standard is based on the ISO 9001 standards but places a more significant focus on regulatory compliance, requiring risk management to be in place for all stages of product realisation, training and supervision of staff, project site specs, and prevention of contamination.

by HSEQ Smart [Claim Listing ]
BSI Training Academy Logo

ISO 13485:2016 Clause by Clause

This two-day course provides an in-depth understanding of ISO 13485:2016. It’s designed specifically for those who are looking to further their knowledge of the management system. 

by BSI Training Academy [Claim Listing ]
LICQual UK Ltd Logo

ISO 13485:2016 Medical Devices Quality Management Systems Lead Implementer

The ISO 13485:2016 Medical Devices Quality Management Systems Lead Implementer course empowers professionals with the knowledge and skills necessary to lead the implementation of ISO 13485 within their organizations.

by LICQual UK Ltd [Claim Listing ]

© 2025 coursetakers.com All Rights Reserved. Terms and Conditions of use | Privacy Policy