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 for this three-session track!

Friday, September 10, 2021 | 10:00-12:00 pm | Virtual
Friday, September 17, 2021 | 10:00-12:00 pm | Virtual
Friday, September 24, 2021 | 10:00-12:00 pm | Virtual

AGENDA

Session 1: Friday, September 10th, 2021

10:00-11:00am Product Strategy and the Product Development Process
An overview of product development and the business of understanding problems and creating meaningful solutions that are profitable
Speaker: Michael Bojanowski, Sr. Product Development Engineer, Engineering Manager, K1C Consulting

11:00-12:00pm FDA Regulations and the Importance of a Solid Quality Management System
How to create a compliance profile and product development systems that will withstand FDA scrutiny and ensure quality products and patient safety
Speaker: Tasha Bond, President, Evergreen Research

Session 2: Friday, September 17th, 2021

10:00-11:00am Product Design and Development (Inputs, Outputs and Controls)
How products are designed, developed, and the associated processes controlled
Speaker: Ethan Franck, Mechanical Design Engineer, Creation Technologies

11:00-12:00pm Risk Management and Mitigation
How do you assess, document, and mitigate the risk profile of your product?
Speaker: Jo Rupprecht, Esq., Manager of Regulatory Affairs and interim Director for the Research Integrity and Compliance Review Office, Colorado State University

Session 3: Friday, September 24th, 2021

10:00-11:00am Testing, Verification and Validation
Strategic use of testing processes and procedures to develop, vet and verify the product fit for its Intended Use
Speaker: Angie Purvis, Regulatory & Quality Management Systems Consultant, Medical Writer, CLIA Lab Director, Diagnostics & Medical Devices, Angie Purvis LLC

11:00-12:00pm Approaches and Options for 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 and how can you successfully change with them?
Speaker: Jo Rupprecht, Esq., Manager of Regulatory Affairs and interim Director for the Research Integrity and Compliance Review Office, Colorado State University

REGISTRATION IS NOW CLOSED. For more information, please contact Natalie Allen, nallen@cobioscience.com.

Early Bird Pricing: $105 (extended until Friday, September 3, 2021)
Members/Non-Members: $125
Group Discount: Contact nallen@cobioscience.com for code

Registration non-refundable but transferable within company.