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ISO 13485:2016 Transition: Are You Prepared?

Wednesday, June 14
1:30 pm - 2:30 pm
Room 49



John Bis

Vice President, Medical Devices Solutions Sales




ISO 13485:2016 will apply across the whole supply chain and will address the entire lifecycle of a medical device. Key changes to the standard include harmonization of regulatory requirements; inclusion of risk management throughout the QMS; additional clarity with regard to validation, verification and design activities; strengthening of supplier control processes; increased focus regarding feedback mechanisms; software for QMS; manufacturing and the medical device. These changes require a well-thought-out plan for implementation by March 2019 and continuation of the standard thereafter.

This session will highlight the actions you should take now in order to successfully transition to the updated standard.


Attendee Takeaways

  1. Understanding of major changes to the standard
  2. Actions needed and when to take them
  3. How to implement


John Bis has over 25 years of experience in the healthcare industry, and currently collaborates with professionals and organizations who serve the medical industry worldwide. Mr. Bis is driven to ensure that BSI clients are provided with quality services that include assessments, CE Marking, business management software tools, training, resource tools and technical expertise that ensures that clients succeed in regard to bringing quality products to the healthcare market. Mr. Bis leads a highly-talented team of account managers.

Helpful links: Building Your Bridge to the Island of ISO 13485:2016 | The Revitalized ISO 13485: Ready for Businesss