Medical Device Product Development Essentials

Now Virtual!

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.

Join us from this three-session track on September 9, 16, and 23, 2020


Early Bird Pricing: $105 (until September 1, 2020)
Members/Non-Members: $125
Group Discount: 15% off 3+ in a group (Contact for code)

Registration non-refundable but transferable within company


Session 1: September 9th, 2020


10:00-11:00am — 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, Inc.


11:00-12:00pm — Design Inputs 
How to identify stakeholder needs and build successful product requirements 
Patrick Parkinson, Program Manager, Meddux Development Corporation

Session 2: September 16th, 2020


10:00-11:30am — Product Design and Development 
How products are developed, key needs and processes 
Lee Travis, VP Design Services, Design Solutions, Inc.


11:00-12:00pm — Risk Management 
How do you document the risk profile of your product? 
Joanne Rupprecht, Esq., RAC, CCEP, Rupprecht Consulting, LLC

Session 3: September 23rd, 2020


10:00-11:00am — 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


11:00-12:00pm: 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?  
Joanne Rupprecht, Esq., RAC, CCEP, Rupprecht Consulting, LLC

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© 2016 Colorado Bioscience Institute

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