ISO 13485:2016 - Webinar CD/Transcript

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ISO 13485:2016 – Preparing for Implementation

ISO 13485:2016 will have a direct impact on your quality system including:

  • Corrective and preventative action
  • Design control
  • Risk management
  • Supplier management

What do you need to know — and do — to remain compliant?

Industry expert Dan O’Leary — President of Ombu Enterprises, LLC — illustrates the revisions and explains the transition plans for the certificates from the current versions (ISO 13485:2003 and EN ISO 13485:2012) to the corresponding new versions(ISO 13485:2016 and EN ISO 13485:2016). Additionally, he’ll point out potential conflicts with the QSR.

In 90 minutes, you will learn:

  • The transition plan for certificates
  • The transition plan for the EU Harmonized Standard
  • The role of ISO 13485:2016 in the MDSAP and Canada’s plan to adopt it
  • The major differences between ISO 13485:2003 and ISO 13485:2016
  • The status of supporting documents such as ISO 9000:2015 and ISO/TR 14969:2004
  • The status of EN ISO 13485:2016 and issues related to the product directives
  • Some potential concerns related to ISO 13485:2016 and the FDA’s QSR

Order today and begin preparing for implementation of ISO 13485:2016.

Creating the procedures, developing the records, and ensuring compliance is a team effort involving many functions and disciplines. This includes people in the following roles:

  • Quality Managers
  • Quality Engineers
  • Quality Auditors
  • Regulatory Managers
  • MDR Handling Specialists
  • Complaint Handling Specialists
  • Risk Managers
  • Data Analysts

Dan O’Leary is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years of experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs.