Implementing ISO 13485

Our Implementing ISO 13485 two-day course has been designed to provide participants with the knowledge and process steps to enable them to effectively implement a quality management system in line with the requirements for ISO 13485:2003 certification.

The course introduces the concepts needed to understand, develop, and implement a quality management system.

Who should attend?

  • Anyone involved in defining, planning, or implementing an ISO 13485 based quality management system
  • Management representatives
  • Implementation team members

Learning objectives

  • Describe the fundamentals of quality management systems
  • Explain the purpose, structure and requirements of ISO 13485
  • Apply a process of implementing a quality management system that meets the requirements of ISO 13485
  • Prepare for ISO 13485

Course Benefits

  • Develop safe and effective medical devices
  • Understand how you can better meet customer and regulatory requirements
  • Understand the requirements of a medical devices audit
  • Plan and carry out effective internal or external audits

Next Steps

  • Lead Auditor: ISO 13485 - Review ISO 13485 and build on the principles of process auditing in accordance with quality management system standards. Work with our training experts to understand the entire audit process at lead level from planning, to managing and reporting on audit results
  • Introduction to: CE Marking - Gain an introduction to the Medical Device Directives and understand their background and key features. On completion of this course, you'll be able to make informed decisions on meeting the requirements of medical device directives, identify the steps required to reduce the risks in the regulatory process and bring products to the EU market much quicker
  • Medical Devices Risk Management: ISO 14971 - Our ISO 14971 risk management training is an essential element for all medical device manufacturers. You will learn how to identify, evaluate and control risks associated with medical devices throughout the product lifecycle, helping you implement a risk management framework to achieve ongoing compliance.