ISO 13485: Quality Management Systems for Medical Devices

In this In-house course provides a comprehensive overview of the requirements of ISO 13485

In-house Training and Consultancy Services

This In-house course 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 In-house 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.

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Sample 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

Recommended Trainer

Will Burton, the 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. Will 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. Will continues to perform QMS audits to ISO 13485 worldwide and has lectured internationally on related topics.