DO YOU NEED TO . . . SOLVE PROBLEMS MORE QUICKLY?
PARTNER WITH A
FULL-SERVICE
ENGINEERING & HEALTHCARE INNOVATOR?
ACCELERATE YOUR DEVELOPMENT CYCLE?
TAMPA BAY RESEARCH & INNOVATION CENTER
SOLUTION?
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Tampa Bay Research & Innovation Center
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MEDICAL DEVICE LIFE CYCLE lit y
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CONTACT US FOR A CONSULTATION
813 • 224 • 7835
tbric.com
tbric@health.usf.edu
ACCESS ANY STAGE OF THE MEDICAL DEVICE LIFE CYCLE IN ONE WORLD-CLASS FACILITY
CONCEPT
DESIGN
DEVELOPMENT
EVALUATION
“Where Healthcare Innovation Meets Industry” PRODUCT DESIGN
We put your concept on the path to market faster and help to minimize surprises. • Concept Design & Development • Project Management • Root-Cause Analysis »» Corrective & Preventative Action (CAPA) Investigations »» Product Failure Investigations • Verification & Validation Testing • Sterilization Evaluation • Engineering & Modeling Services On-Site • Reverse Engineering
KEY PARTNERS
• Regulatory Services »» Design History File Development »» Regulatory Clearance; Domestic & International »» 21 CFR 820.30 Development Process • Design Diversity »» Single-use Disposable Instruments »» Reusable Instruments »» Electromechanical Devices »» Laparoscopic Devices
EVALUATION SERVICES
We prepare you for your FDA application with our full suite of testing services. • Pre-Clinical »» Compliant with FDA 21 CFR Part 58 (GLP) »» Comparative Studies »» Survival Studies »» In-Vitro Performance Studies • Verification & Validation Testing • Procedural Investigations • Surgical Instruments & Procedures • Sterilization Evaluation
HUMAN FACTORS/ USABILITY SERVICES We help you stay compliant with regulatory changes. • Innovation Workshops • User Evaluations • Usability Reports • uFMEA • Procedural Maps • Focus Groups
OUR CLIENT EXPERIENCE
90,000
Ranges from start-ups to multi-billion dollar, global companies TITLE:
FACILITY FEATURES
SQ. FT.
39
State-of-the-art facility.
Hospital-grade surgical stations
25,000
7
Dedicated meeting space
SQ. FT.
Day/ week availability
WHY SELECT US? “Working with the team at TBRIC is always invigorating. Their knowledge, along with a ‘can do’ attitude, provide thoughtful solutions to complex clinical and mechanical scenarios. I’ve enjoyed the process and look forward to further joint projects.’’ Peter Arneson, Senior Product Manager Cooper Surgical
“Timelines in our industry are critical. CAMLS makes available equipment and services that permit new products to be tested and modified within days or weeks rather than months. It allows our small firm to compete successfully by permitting us access to resources normally only available in larger firms.” Geary Havran, President and Chairman of the Board, NDH Medical, Inc.; Chair, Florida Medical Manufacturers’ Consortium, Inc.
“For medical device manufacturers innovating new products, a critical step in the process is design validation. The unique studies, both simulated and actual use, provided by TBRIC, are invaluable to the validation process.’’ Brian Mayte, CEO, Regulatory Compliance Associates, ® Inc.
CONTACT US TODAY FOR A CONSULATION 813 • 224 • 7835 tbric.com | tbric@health.usf.edu