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North Florida Medical Device Workshop presented by Empirical Consulting
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North Florida Medical Device Workshop presented by Empirical Consulting

11/5/2015
When: November 5, 2015
8:30AM until 3:15PM
Where: Corazon Cinema and Café in Downtown St. Augustine
36 Granada Street
St. Augustine, Florida  32084
United States
Presenter: Empirical Consulting
Contact: Meredith May

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North Florida Medical Device Workshop presented by Empirical Consulting 

 

Join medical device industry thought leaders Thursday, November 5, 2015, for a one-day intensive workshop to get the inside track on how to quickly and efficiently gain clearance/approval. Jodi Anderson, M.S., policy analyst for CDRH, will discuss the cutting-edge IMDRF Regulated Product Submission pilot program designed to accelerate your path to market and decrease your costs when submitting a 510(k) premarket notification or premarket approval. From Dawn Lissy, president of Empirical, you’ll learn about common mistakes innovators make on the road to market and how to avoid them. Victoria Trafka, president and lead consultant for Engineering & Quality Solutions, Inc., will teach you about finite element analysis (FEA) and how its data affects your submission. Linda Braddon, president of Secure BioMed Evaluations, will share her expertise on the FDA’s expectations for usability studies. Alejandro Sánchez de los Reyes, account manager at MediaLocate, will discuss why localization is about so much more than just translation when it comes to entering foreign markets. From Don Tumminelli, manager of validation and testing services at HIGHPOWER Validation Testing & Lab Services, you’ll learn about the central service department and various validation testing required by regulatory agencies around the world. 

 

For the full agenda and registration information, click here.

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