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5
May

POSTPONED: Medical Device Product Development Essentials

Tuesday, May 5, 2020
8:00am—4:00pm
Cerapedics
11025 Dover St., Ste. 1100
Broomfield, CO 80021 United States

POSTPONED – New date to be announced

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

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?

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

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?

3:30-4:00pm Review of the Day, Q&A Session

Registration Fee: $195 per person, includes breakfast & lunch and course materials.
Registration non-refundable but transferable within company

Thank you to our program partner: