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16
Sep

Medical Device Product Development Essentials—Virtual Workshop

Wednesday, Sep 16, 2020
10:00am—12:00pm

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 nallen@cobioscience.com for code)
Registration non-refundable but transferable within company.

Agenda:

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, Colorado State University

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, Colorado State University

 

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