NQA ISO 13485 (Medical Devices) Introduction and Implementation Training

Course Location VIRTUAL
Cost £799
Type of course in situ
Online booking
Course provider NQA Certification and Training
Available dates for this course
From   27/09/2021   Until   28/09/2021

Gain insight into the application of ISO 13485:2016 as the basis for a Quality Management System used by medical device manufacturers.

Course aims

The aim of this course is to provide delegates with knowledge of the requirements of the ISO 13485:2016 standard, discussing key principles and concepts as well as how the standard interacts with ISO 9001:2015, the European Medical Device Directive and the US FDA’s Quality System Regulations.

Delegates will gain the knowledge to be able to understand, develop, implement and maintain ISO 13485:2016 management system.

What will I learn?

  • How to understand and describe the purpose and intent of a quality management system in the context of medical devices.
  • How to summarise the contribution that ISO 13485:2016 can make towards the development of safe, effective and compliance medical devices.
  • How to state the structure, key points, aims and objectives of the ISO 13485 standard.

Is this course right for me?

This course is aimed at:

  • Anyone involved in the implementation / operation of the standard
  • Senior Management, Quality Managers, Regulatory / Compliance Managers
  • Auditors
  • Consultants

Book your place above or contact us at training@nqa.com.

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