TAMPA BAY RESEARCH & INNOVATION CENTER
SOLVE PROBLEMS
FULL-SERVICE
ACCELERATEACCELERATEYOUR DEVELOPMENT
CYCLE?
SOLVE PROBLEMSMORE QUICKLY?
PARTNER WITH A
FULL-SERVICEENGINEERING &
HEALTHCARE INNOVATOR?
DO YOU NEED TO . . .
Tampa Bay Research & Innovation Center
MEDICAL DEVICELIFE CYCLE
Product D
esign
Product E
valu
atio
n S
ervi
cesU
sability Studies
SOLUTION?
813 • 224 • 7835CONTACT US FOR A CONSULTATION
tbric.com
PRODUCT DESIGNWe put your concept on the path to market faster and help to minimize surprises.
EVALUATION SERVICESWe 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 SERVICESWe help you stay compliant with regulatory changes.
• Innovation Workshops• User Evaluations• Usability Reports• uFMEA• Procedural Maps• Focus Groups
• 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
• 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
ACCESS ANY STAGE OF THE MEDICAL DEVICE LIFE CYCLEIN ONE WORLD-CLASS FACILITY
KEY PARTNERS
CONCEPT
“Where Healthcare Innovation Meets Industry”
TITLE:
FACILITY FEATURES
7Day/ week availability
90,000 SQ. FT.
State-of-the-art facility.
39Hospital-grade surgical stations
25,000 SQ. FT.
Dedicated meeting space
OUR CLIENT EXPERIENCERanges from start-ups to multi-billion dollar, global companies
DESIGN DEVELOPMENT EVALUATION
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 ManagerCooper 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 CONSULATION813 • 224 • 7835
tbric.com | [email protected]
