Industry News

NAMSA Speakers Around the Globe

In Regulatory, Toxicology by Kristi Posadny

NAMSA is more than just testing, clinical and regulatory services.  We also want to make sure our clients our educated on the various topics in the medical device industry.  Whether you need to know about biocompatibility testing, functional studies, regulatory or clinical, NAMSA speakers are available to educate you further on these topics.

In the next month, you can find our experts speaking at number of conferences throughout the globe.  For our clients in China, we have two speakers at BioDevice Shanghai on May 28th-29th.  Mr. An Liu will be speaking about how Chinese medical device companies can navigate the US market.  Dr. Roy Martin will present at the same event on Functional Studies for Active Implantable Medical Devices.

In June we will be at 3 events in Europe.  The first is an event we are proud to be a sponsor of, 2ndAnnual Designing Medical Devices: Advanced Solution for Today’s Designers.  This event will take place on June 2nd from 12:00 p.m.-8:00 p.m. at the Movenpick Hotel.  Dr. Nicolas Martin will present on the Chemical Characterization of Materials.

Are you confused by the new EU regulations?  Dr. Jean Pierre Boutrand will be speaking about this topic at MedTec Europe on June 3rd.  This presentation will go over the changes already happening since the European Parliament resolution on PIP on June 2012, calling for strict approval rules for Notified Bodies, stronger preclinical (and clinical) evaluation of new Medical Devices and centralized review of data together with unannounced inspections for high risk devices. The new regulation is expected to come into force from 2015 to 2018.  The practical impacts for Medical Devices biocompatibility and effectiveness data submission will be reviewed in details in the presentation.

The China Medical Device Market grew an estimated annual growth of 20%, becoming the 4th largest market in the world.  If you were unable to attend our symposium in Frankfurt, you can still learn about this emerging market and how to enter it.  An Liu will be speaking at a China Breakfast Meeting on June 4th at Medtec Europe.  Don’t miss the opportunity to learn about the regulations and the market potential to expand your product line into China.

Also speaking at MedTec Europe will be NAMSA pathologist Antione Alves.  His presentation Biocompatibility testing and safety assessment for Smart medical devices: tips for avoiding pitfalls which will discuss how microscopic analysis of tissues from non clinical studies are Pivotal in the biological assessment of biomaterials.

To learn more information about any of our speakers at MedTec Europe, please visit our Events page.

Finally, NAMSA is proud to be a sponsor the 3rd Annual European Medical Device and Diagnostic Regulation Conference in Brussels.  Dr. Vincent Legay and Katherine Clark will be presenting on Practical Application of Updated International Standards.  Dr. Legay and Ms. Clark will discuss Risk Management and Quality Management Systems and what these mean to your product development process.

Next Steps

Authors:

Kristi Posadny is the Marketing Event Coordinator at NAMSA, focusing on increasing NAMSA's visibility at events and bringing our knowledge to the medical device, regenerative medicine and combination device industry. She holds a BBA in Communication, Journalism and Related Programs from Miami University. Kristi has held various roles at NAMSA for nearly 10 years, in areas such as Chemistry, In Vivo and In Vitro Biocompatibility and now Marketing.