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Global Regulatory Outlook: 2017 and Beyond

Wednesday, June 14
2:45 pm – 4:00 pm
Room 45



Evangeline Loh, Ph.D.

Vice President of Global Regulatory Affairs




Keeping a finger on the pulse of regulatory changes taking place worldwide is hard to do, but nonetheless imperative. This session will provide a high-level overview of the more significant global regulatory changes that will impact orthopaedic manufacturers in the next two years. These include European Medical Device Regulation, ISO 13485:2016, MDSAP and U.S. FDA changes, as well as other global topics of interest. Ms. Loh, who leads the regulatory team at EMERGO, returns to OMTEC to provide perspective on strategies and risks to consider with these wide-ranging and sometimes overlapping matters.

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


Attendee Takeaways

  1. High-level view of the top regulatory changes impacting the orthopaedic industry
  2. A timeline for preparation and implementation
  3. Resources to remain updated and educated


Evangeline Loh, Ph.D., RAC (US & EU), Vice President of Global Regulatory Affairs, EMERGO, leads the regulatory team supporting Emergo’s 2,700+ medical device and IVD clients globally. She has personally assisted hundreds of medical device and IVD companies, including dozens of orthopaedic companies, with regulatory strategy, registration and consulting projects. Before joining Emergo, Dr. Loh was a Regulatory Affairs Scientist with Cook. She has published numerous articles about the different medical device regulatory systems.

Helpful links: 3 Points to Consider from the Long-Awaited EU Medical Device Regulations | Building Your Bridge to the Island of ISO 13485:2016