Medical Device Product Development Essentials

Tuesday, May 1, 2018 | 8:00-4:00pm 

NITA Training Center

1685 38th Street Suite 200

Boulder, CO 80301

This program features industry experts who will provide a comprehensive introduction to some of the topics encountered during the development of medical products. This presentation is designed for those who are new to medical device engineering or who work within or in conjunction with the development teams and want to learn more about the essential steps within product development. This program will also serve as a refresher course for those who may be working in new areas of responsibility or as a foundation for those working within other disciplines.

7:30- 8:00am

Breakfast and Registration


Regulations and the Product Development Process 
An overview of the responsibilities to FDA, accountability, and how the product development process lines up with regulations 
Lee Travis, VP Design Services, Design Solutions


Design Inputs 
How to identify stakeholder needs and build successful product requirements 
Natasha Bond, Nordson Medical





Product Design and Development 
How products are developed, key needs and processes 
Lee Travis, VP Design Services, Design Solutions



Risk Management 
How do you document the risk profile of your product? 
Steve Beauchamp. Director of Quality Assurance, Dohmen Life Sciences



Networking Lunch


Testing and Verification: Proving you've designed the product right 
Strategic use of testing to develop, vet and verify the product 
Validations: Proving you've designed the right product 
How validations are used to prove customer's needs are met, and the product is reliable and safe 
Natasha Bond, Nordson Medical


Design Transfer 
When is your product ready for commercial launch and how to transition it (and you) from R&D into stable, traceable manufacturing 
How do FDA expectations change at this point?  
Steve Beauchamp. Director of Quality Assurance, Dohmen Life Sciences


Review of the Day, Q&A Session

Course Fee: $195

Group discount for (3) or more from the same company. Contact Tracey for the promo code 

Course fee includes course materials, breakfast and lunch


Registration non-refundable but transferable within company

Program Partners:

© 2016 Colorado Bioscience Institute

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