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.
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.
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:
Once you have registered and made the full payment, you will be given login details to access the course.
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.