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

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 Quality Management System 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

Book now

We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.

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Previous customers include...

  • Acrostak
  • Almirall Hermal GmbH
  • Bayer Healthcare
  • Bayer Pharma AG
  • BioTop Medical
  • Dermal Laboratories Ltd
  • Elekta Oncology Systems Ltd
  • GSK Consumer Healthcare
  • Imtool Sarl
  • Johnson & Johnson Medical Ltd.
  • Magstim
  • MED-EL Medical Electronics
  • Mediplus Ltd
  • Microbiosensor Limited
  • Orion Pharma
  • Otsuka Pharmaceutical Europe Ltd
  • Pfizer Ltd
  • Remote Diagnostic Technologies Ltd
  • Saudi Food and Drug Authority
  • SolasCure
  • SPD Development Company
  • SPD Development Company Limited
  • Torbay Pharmaceuticals
  • Toshiba Medical Europe
  • University of Cambridge
  • University of Dundee
  • Vectura
  • Vision RT

Good course

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

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