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Management Forum

ISO 13485: Quality Management Systems for Medical Devices

Compare the requirements of ISO 13485 and ISO 9001, understand the role and responsibilities of quality management. Consider the relationship between ISO 13485 and ISO 14971 'Application to Risk Management to Medical Devices'.

Find out more

  • Format: Bespoke training
  • CPD: 12 hours for your records (depending on your requirements)
  • Certificate of completion

Course overview

This seminar will provide a comprehensive overview into the use of ISO 13485 as the basis for a quality management system (QMS) for medical device manufacturers. It will review the requirements of ISO 13485 and will compare it to ISO 9001 and the FDA’s Quality System Regulation. In addition delegates will gain an appreciation of the relationship between ISO 13485 and ISO 14971 ‘Application of Risk Management to Medical Devices’. The benefits of implementing a QMS will be discussed and key advice on handling complaints will be provided.

Why you should attend

  • Gain a comprehensive overview of ISO 13485:2016
  • Brief overview of the EU Medical Devices Regulation (MDR) and in-vitro Medical Devices Regulation (IVDR)
  • Compare the requirements of ISO 13485 and ISO 9001
  • Understand the roles and responsibilities of quality management in ISO 13485
  • Transition planning from EN ISO 13485:2012 to EN ISO 13485:2016 what needs to be achieved before February 2019
  • Consider the relationship between ISO 13485 and the MDR
  • Explore the relationship between ISO 13485 and ISO 14971 ‘Application of Risk Management to Medical Devices’
  • Discover the benefits of implementing a Quality Management System
  • Preparation for the Unannounced Audits as now incorporated into the MDR
  • Take away key advice on handling complaints

Who should attend?

  • Quality managers
  • Quality assurance personnel
  • Regulatory affairs managers
  • Internal and external auditors
  • Medical device designers and developers
  • All those who are involved with the implementation

Programme

Introduction to ISO 13485 and Medical Device Regulation Conformity Assessment

Introduction to the EU Medical Devices Regulations

  • The pitfalls and opportunities
  • The interested parties
  • The actions to be taken during the transition period

Compare the requirements of ISO 13485 and ISO 9001 and update on the ISO 9001: 2015 revisions

  • The advantages and disadvantages of continuing with certification to both

Interpretation of ISO 13485 and what it means in practice for the QMS requirements in the MDR

  • Including timescales

How to achieve ISO 13485 certification

  • Understanding the new requirements and structure
  • Performing the gap analysis
  • Managing your transition to the 2016 version of the Standard

Examples of ISO 13485 non-compliances

  • How they are graded
  • How to fix them

Understanding the roles and responsibilities of top managment in ISO 13485

The relationship between ISO 13485 and ISO 14971 ‘Application of Risk Management to Medical Devices’

  • With practical examples

Compare and contrast the requirements between ISO 13485 and FDA’s Quality System Regulation

Unannounced Audits

  • What to expect
  • How to prepare

Successful handling of Post Market issues

  • Complaints
  • Post Market Surveillance
  • Field Safety Notices
  • Field Safety Corrective Actions
  • Vigilance Reporting

Benefits from implementing a QMS

  • Better meet your customer and regulatory requirements
  • Increase efficiency and find cost savings
  • Improve your company supply chain
  • Develop safe and effective medical devices
  • Basis for demonstrating regulatory compliance

Discussion and workshops will take place throughout the two days

Will Burton

Will Burton, Director of Russell Square Quality Representatives (RSQR) Ltd, is engaged in providing a range of consultancy and training services to the international medical device, pharmaceutical and biotechnology industry sectors. Prior to founding RSQA in 1995, Will was the Professional Services Manager of the Manufacturer Registration Scheme Business Unit of the UK Medical Devices Agency (now MHRA).

He is a Pharmacist, Medicinal Product Qualified Person, Medical Device Expert and registered international lead assessor. He managed the UK team of medical device expert assessors performing worldwide quality systems audits of medical device manufacturers against the requirements of the Department of Health’s Quality Systems Documents which formed the foundation for ISO 13485. He has very extensive auditing and quality systems experience and was closely involved in the selection, training and monitoring of UK Notified Bodies. He continues to perform QMS audits to ISO 13485 worldwide and has lectured internationally on related topics.

More details

We don't have any currently scheduled dates for this course but we can customise it to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

See below or contact us to discuss your requirements.

Reviews of IPI's ISO 13485: Quality Management Systems for Medical Devices training course


Good course

Sep 19 2018

Yousf Awadh Alshahrani
Senior Biomedical Specialist, Saudi Food and Drug Authority

Sep 20 2017

Helpful, friendly and informative. The course materials were delivered and presented in a clear way. Speakers even clear for a non native english

Houssam Mohammed AlKahtani
Biomedical Specialist, Saudi Food and Drug Authority

UK

  • Bayer Healthcare
  • Dermal Laboratories Ltd
  • Elekta Oncology Systems Ltd
  • GSK Consumer Healthcare
  • Johnson & Johnson Medical Ltd.
  • Mediplus
  • Microbiosensor Limited
  • Otsuka Pharmaceutical Europe Ltd
  • Pfizer Ltd
  • Remote Diagnostic Technologies Ltd
  • SolasCure
  • SPD Development Company
  • SPD Development Company Limited
  • The Magstim Company Ltd
  • Torbay Pharmaceuticals
  • University of Cambridge
  • University of Dundee
  • Vectura
  • Vision RT

Germany

  • Almirall Hermal GmbH
  • Bayer Pharma AG

Netherlands

  • BioTop Medical
  • Toshiba Medical Europe

Switzerland

  • Acrostak
  • Imtool Sarl

Austria

  • MED-EL Medical Electronics

Finland

  • Orion Pharma

Saudi Arabia

  • Saudi Food and Drug Authority

Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy