Medical Device Product Development Essentials

Thursday, May 18, 2017 | 8:00-4:00pm
NITA Training Center
1685 38th Street Suite 200
Boulder, CO 80301

Summary:
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.

Agenda:

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, Program Director, Vention 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?
Mitch Lewandowski, 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, Program Director, Vention 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?
Chad Herremans, Manager Quality Engineering, Vention Medical
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 tnilson@cobioscience.com to inquire.

Course fee includes course materials, breakfast and lunch

Registration non-refundable but transferable within company

Program Partners: