Presentation: Device Design Controls When the Combination Product Uses an Off-the-Shelf Device Versus Custom Developed Device

Speaker:  Lilli Zakarija

Date: May 5, 2017

Event: Drug Development & Delivery Innovation Networking Summit

Executive Summary


EdgeOne Medical President Lilli Zakarija provides an overview of the key issues and topics regarding Device Design Controls when using an Off-The-Shelf (OTS) Device versus a Custom Developed Device to a diverse crowd of Biopharma executives.

Case Study: Device Qualification

Leading Device Qualification for Delivery System of Biologic for Phase II Clinical Study while Leveraging EdgeOne Medical QMS

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Case Study 2

Conducting Design Verification and Validation Testing on Custom Device

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Case Study: Design Qualification

Case Study: Design V & V

Stay Informed

Leading Device Qualification for Delivery System of Biologic for Phase II Clinical Study while Leveraging EdgeOne Medical QMS

Conducting Design Verification and Validation Testing on Custom Device

Access the EdgeOne Medical Combination Product Development & Testing Blog

Learn More
Learn More
Access Blog