ISO 13485: Quality Management Systems for Medical Devices (London, United Kingdom - September 19-20, 2018)

  • ID: 4400296
  • Conference
  • Location: London, United Kingdom
  • 2 Days
  • Management Forum
  • Conference Dates: September 19-20, 2018
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Delivering safe medical devices

This seminar has been designed to provide a comprehensive overview into the use of ISO 13485 as the basis for a Quality Management System (QMS) for medical device manufacturers. The course will review the requirements of ISO 13485 and will compare 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

* Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.

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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

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  • Will Burton Mr Will Burton,
    Director ,
    Russell Square Quality Representatives (RSQR) Ltd

    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.

  • Paul Sim Mr Paul Sim,
    Regulatory Affairs Manager ,
    BSi Group.

    Paul Sim, Regulatory Affairs Manager, BSi Group. Paul has worked in the healthcare industry for 34 years and is currently Project Managing BSI’s implementation of EU Commission Recommendation 2013/473/EU dealing with Unannounced Audits. Joining BSI in August 2010 leading the BSI effort working with the Saudi Food & Drug Authority on the implementation of the SFDA Medical Device Interim Regulations.

    Previously he held senior RAQA leadership positions at Spacelabs Healthcare, Teleflex Medical, Smiths Medical, Ohmeda (formerly The BOC Group healthcare business)

    Medical Device experience is across a very broad range of devices including: anaesthesia systems, patient monitors, vapourisers, ventilators, breathing circuits, single use sterile disposables and devices for re-use, infant warmers, incubators, steralisers, autoclaves, operating tables, infusion pumps and associated disposables, urinary catheters, surgical instruments, diagnostic cardiology etc.

    Paul is a member of the Association of British Healthcare Industries (ABHI) Technical Policy Group and is Convenor of the ABHI ISO TC 210 Mirror Group. Convenor of the BSI Committee, which monitors all of the work undertaken by ISO TC 210, and Convenor of the BSI Sub-committee dealing with Quality Systems. As UK Delegation Leader to ISO TC 210, Paul is also actively involved in the work of national, European and international standards’ committees, dealing with revisions to the ISO 9000 series, ISO 13485, ISO 14971, ISO 15223 and others. He is Deputy Chairman and Council Member of Barema (British Anaesthetic & Respiratory Manufacturers Association), also a Member of the Association of Anaesthetists of Great Britain and Ireland (AAGBI) Safety Committee.

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  • 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
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United Kingdom

Venue to be announced shortly.

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