In 2012, the European Union issued new versions of EN ISO 14971 on medical device risk management and EN ISO 13485 on quality management systems for devices. The two standards are now harmonized. You need to implement these major changes!

One source of confusion is the various versions of standards. This presentation explains the global system of standards, distinguishing between the international version, regional versions (such as the EU) and national versions (such as the UK, Canada, and the US). In addition, our speaker clarifies the role of harmonized standards and explains the EU’s regional version of the standards and their linkage to the directives.

The focus of the presentation is the impact of these changes on the Medical Device Directive. EN ISO 14971:2012 primarily affects the Essential Requirements, while EN ISO 13485:2012 deals with the conformity assessment paths. Our speaker explains the impact on both Annex I Essential Requirements and Annex II Full Quality Assurance System and also addresses the content deviations in EN ISO 14971 which limit or restrict certain risk management practices.

This audio conference covers:

• The impact of EN ISO 13485:2012 on the conformity assessment paths, especially MDD Annex II
• The impact of EN ISO 14971:2012 on the Essential Requirements, MDD Annex I
• The differences among international, regional and country standards and how to distinguish them
• The role of harmonized standards in the EU and how to determine when a standard becomes harmonized
• How to get ready for the changes

About the speaker:

Dan O'Leary is 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. He has a Masters degree in mathematics and is an ASQ-certified biomedical auditor, quality auditor, quality engineer, reliability engineer and Six Sigma Black Belt. He ia also certified by APICS in resource management.

Who should attend?

• Any company with a CE Mark to the MDD, AIMD or IVDD
• Regulatory affairs managers
• Risk management professionals
• Quality managers
• Quality engineers