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Jul 2017


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ISO 13485, ISO 14971, Quality Document Management, and Risk Management for Medical Devices


Medical device manufacturing companies generate a copious number of documents when implementing a Quality and a Regulatory Management System.

Various applications are available for purchase but at a high cost and unfortunately with ongoing maintenance license fees and the use of the service provider’s cloud systems which at times becomes questionable with current cybersecurity issues we all face.

This session will take through a new paradigm in work practices for managing documentation without the need to continuously search and question obsolescence and relevancy. It will introduce the use of Microsoft Excel and hyperlinks to manage particular areas of document and project management.

You will learn how to best manage your documents, remain compliant to ISO 13485 but most importantly eliminate one of the biggest time wasters when documents are saved by one person and retrieved by a different person in your organisation.

ISO 13485:2016 will be the reference document for all matters in this course.

Learning Objectives:

Upon completing this course participants will:

  • Understand and implement a document naming convention for their department, pursuant to sections in ISO 13485
  • Understand inputs into a Quality and Regulatory Management System
  • Adopt a procedural approach when documents are saved and are continuously traceable from the time they are first created
  • Incorporate the approach as a new discipline for all current and new staff joining the organisation
  • Ensure continuous use of the new procedure through ongoing audits of the practice throughout the organisation
  • See immediate time savings when the approach is continuously used
  • Have in place a clearly defined document indexed maintainable folder structure
  • Remain compliant to ISO 13485

Who will Benefit:

This course is designed for all personnel tasked with, creating, maintaining ongoing updates of documentation associated with a Quality Management System and Regulatory Affairs. This includes individuals working in department with Quality Management Systems, Engineering and Regulatory Affairs accountabilities. The following personnel will benefit from the course:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • Design engineers
  • Process owners
  • Quality engineers
  • Quality auditors

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:



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