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Understanding ISO 13485:2016 - Online Academy

5 weeks - 1 hour per week

4 February - 1 March 2019

Online Academy

The publication of ISO 13485:2016 marks a turning point in Quality Management Systems for those involved in the lifecycles of medical devices. Organisations presently complying with ISO 13485:2003 now have until March 2019 to comply with this new revision, with its increased requirements around risk management and documentation.

This essential 5 module course will allow you to get a head start on your transition plans and become familiar with ISO 13485:2016.

What is an Online Academy course? 

Online academy is a new online, interactive and engaging education tool designed to maximise learning for professionals with busy schedules and/or small training budgets.

The online academy brings alike professionals together and gives you the opportunity to share ideas and questions via the discussion forum creating your own professional community. Our on-demand feature means the content is available as and when you need it allowing greater flexibility to your professional development and learning. 


Over 5 weeks students will learn through:

  • 5 modules, split up into multiple bitesize recorded videos
  • Quizzes to test your knowledge
  • Revisit the content with unlimited access to all the materials for 2 months
  • Access the discussion forum to interact with other students
  • Direct contact with the trainer through the forum during the 5 weeks the course is running
  • Additional content such as materials and white papers available to download

Richard Young

Richard Young has over 20 years’ experience in the medical device industry, working with products from Class III implants to electromedical infusion systems. He has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited

• Understand documentation structure required by the standard
• Investigate best practice for document control
• Examine management responsibility and resource management requirements
• Explore product realisation from the design process to manufacturing
• Understand validation of aspects of manufacturing process
• Comprehend business monitoring
• Gather and analyse data using internal audits and corrective action processes

This course will be useful for anyone considering the application of ISO 13485:2016, or who needs an overview of Quality Management Systems for medical devices. It will be applicable for professions in:

  • Quality
  • Engineering
  • Product design
  • Regulatory affairs


100% of participants who took the course in 2017 have found it to be beneficial in their day to day role and the learning to be applicable to their own work whilst the course was running.

What happens during an Online Academy course?

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This online academy course can be accessed from 5th November 2018. 1 module will be uploaded per week, allowing you to study at your own pace. Your trainer will welcome any questions that arise throughout your course.

Please note that full payment must be made prior to the course start date in order to receive your login details to begin the course.

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