From proof-of-concept prototype to First-In-Human study

DESIGN & DEVELOPMENT

DESIGN & DEVELOPMENT SERVICES

Engineering

DESIGN OPTIMIZATION

Refine your design approach, prepare your Design History File, and de-risk your pre-clinical testing strategy. The JI can help you:

    • Generate design specifications through anatomical chart reviews and bench testing
    • Identify and mitigate clinical risks through design and process modification
    • Iterate and test physical prototypes to update and inform design specifications
    • Prototype pre-qualification units on industry-standard equipment for seamless manufacturing transfer
FACILITIES & EQUIPMENT
Engineering

VERIFICATION & VALIDATION

Demonstrate your device meets specifications in preparation for your regulatory submission. The JI can help you:

    • Guide your pre-clinical testing strategy
    • Develop and qualify custom test methods and generate testing protocols
    • Design and qualify anatomical models based on clinical data and disease-state geometry
    • Execute V&V testing and Good Laboratory Practices (GLP) in vivo studies
Pre-clinical device testing
Office of Regulatory Services

REGULATORY SUBMISSION PREPARATION & SUPPORT

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.

Regulatory Services
Office of Quality Services

QUALITY MANAGEMENT SYSTEM SUPPORT

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.

Office Of Quality Services

COMMITMENT TO QUALITY

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