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

8:00-9:00am

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

9:00-10:00am

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

 

10:00-10:30am

Break

10:30-11:30am

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

 

11:30-12:30pm

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

 

12:30-1:30pm

Networking Lunch

1:30-2:30pm

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

2:30-3:30pm

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

3:30-4:00pm

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


REGISTER NOW

Registration non-refundable but transferable within company



Program Partners:

© 2016 Colorado Bioscience Institute

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