ISO 13485 Training courses

• Get an overview of quality management system requirements
• Discover how ISO 13485 impacts the design, development and production of medical devices
• Learn why ISO 13485 compliance is essential to meeting customer and legal requirements

• Discover step by step how to design, plan and put in place your own ISO 13485 system
• Learn how to maintain best practice and achieve ISO 13485 accreditation

• Use your existing knowledge of ISO 13485 to help your organization maintain compliance
• Learn how to stay ahead of new industry developments and discover links between medical devices quality management and ISO 14971 medical device risk management.

• Lead teams of auditors through the entire audit process
• Become confident recommending follow up action to achieve ISO 13485 compliance.
• Discover the importance and relevance of ISO 14971 medical devices risk management and keep up with industry developments as a recognized independent ISO 13485 expert.

Our new ISO 13485:2016 Senior Management Briefing training course highlights the responsibilities of Senior Management in ISO 13485:2016.

• We explain the CE Marking process and routes to compliance with the EU Medical Devices Directive
• Discover how to open up new business opportunities in the EU market.

• Get in-depth knowledge of the European Medical Devices Directive, EU regulations and the entire CE Marking process. 
• Learn to assess your devices to identify risks and report changes to ensure conformity.