May 9 - What's New in ISO 10993-1:2018
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May 9 - What's New in ISO 10993-1:2018

American Preclinical Services is teaming up with Surfaces in Biomaterials Foundation to put together a night of networking and discussions on the new release of ISO 10993-1:2018. Two industry professionals will provide insights into biological evaluation, chemical characterization testing, FDA guidance documents, submission requirements, and MDR requirements.

5/9/2019
When: 4:30 PM
Where: American Preclinical Services
9055 Evergreen Boulevard
Coon Rapids, Minnesota 
United States
Contact: Ingrid Beamsley
612-351-2365


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Speakers:

Mac McKeen, MBA, RAC, Fellow-Regulatory Science at Boston Scientific

Ed Rankin, Sr. Scientist at Medtronic Physiological Research Laboratories

 

Thursday, May 9, 2019
4:30 PM - 6:00 PM: Registration & Networking
6:00 PM - 7:30 PM: Program

 

Registration is FREE

Food and beverages provided

 

Exhibit Opportunities are available for $500.
Click on Register and select Exhibit on the Attendee Selection tab.

 

American Preclinical Services
9055 Evergreen Blvd., Coon Rapids, MN

 

Regulatory Considerations:

With the release of ISO 10993-1:2018, there is a continued focus in biological safety planning and implementation processes, as well as the characterization of materials. Medical device manufacturers must go beyond the simple process of identifying a set list of biocompatibility tests when evaluating a device's biological safety. This session will take a look at the major changes introduced within ISO 10993-1:2018, and also discuss how manufacturers can prepare for implementation of these new requirements.

·FDA Guidance documents
·What goes in the submission
·What are the new MDR requirements 

   

Mac McKeen has over 30 years of experience in the medical device industry in regulatory and quality roles focused on the development, clinical study, and regulatory approvals of cardiovascular devices and is currently a Fellow at Boston Scientific with previous leadership roles at Guidant, Medtronic, St. Jude Medical, Cardiac Science and Phillips Medisize.  He also serves as an Adjunct Professor at the University of Minnesota instructing a 4000 level course on medical device development and is also a Faculty Director within the college of Continuing and Applied Professional Studies and is a member of the UMN Medical Device Innovation Graduate Degree program. He is actively involved in advocacy and collaboration with the FDA through industry associations including AdvaMed, MDIC and Medical Alley.  He holds a BS in Industrial Technology from Iowa State University and an MBA from the University of Dallas and is RAC certified.

 

     
   

Ed Rankin is a Senior Scientist at Medtronic with 18 years’ experience using ISO 10993 to write biological evaluations, perform biocompatibility testing, and coordinate regulatory submission information for a wide variety of medical device applications. He holds a BA in Biology from Taylor University and a Master of Biological Sciences degree from the University of Minnesota.

 

 

 

 

 


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