Medical Device Product Development Essentials
Thursday, April 4, 2019
8:00-4:00pm

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 Patrick Parkinson, Program Manager, Meddux Development Corporation
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, Quality Director, Eversana
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 Chad Herremans, VP Quality & Operations, Meddux Development Corporation
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, Quality Director, Eversana
3:30-4:00pm Review of the Day, Q&A Session