Refine your design approach, prepare your Design History File, and de-risk your pre-clinical testing strategy. The JI can help you:
Demonstrate your device meets specifications in preparation for your regulatory submission. The JI can help you:
Prepare Submissions for the FDA: The JI can help ease the burden of the regulatory submission process and maximize your engagement with FDA through assistance in the pre-submission process or preparation of your final submission.
To provide the best quality care to patients, it is essential that your device be designed and tested for its effectiveness and safety under a Quality Management System (QMS). The JI can provide the necessary tools and resources to bring your QMS to meet these standards and get your device implemented into clinical practice.
The Jacobs Institute is focused on accelerating the research, design, development and manufacture of innovative high-quality, clinically relevant engineering solutions and products to impact the treatment of vascular, neurological, and related diseases.
We are registered to ISO 13495:2016 by SRI Quality System Registrar. Learn more about our quality management system