Medical Device Product Development Essentials

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!

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: 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

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.

Session 2: 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

11:00-12:00pm Risk Management and Mitigation

How do you assess, document, and mitigate the risk profile of your product?

Session 3: 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
Verifications and Validations: Testing, analyzing and provided the support needed to commercialize Where does the use of Consensus Standards Come In?

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?

REGISTER

Early Bird Pricing: $105 (until August 31, 2021)
Members/Non-Members: $125
Group Discount: Contact nallen@cobioscience.com for code


Registration non-refundable but transferable within company.