Catheter Research, Inc (CRI) is a market leader in medical device manufacturing and product development. CRI specializes in catheter design / assembly, medical tubing /extrusion, and OBGYN disposables. CRI provides customers with unbeatable service, and offers premier integrated services in project management, lean manufacturing techniques, supply chain controls, and regulatory compliance.
Premier Integrated Services & Capabilities:
Contract Manufacturing
CRI takes a team approach to transferring manufacturing lines into our facility. We assign a dedicated Project Manager at the start to ensure all deliverables are documented and tracked. We focus on improving process and product during the transfer, resulting in lower costs and improved quality. CRI minimizes the effort for customers, making transfers seamless and smooth.
Design & Engineering
CRI’s engineering department offers an extensive and diverse background in all phases of engineering design and development. We specialize in medical device disposables, from concept stage through medical packaging and distribution. We focus on design for manufacturability, with emphasis on creating repeatable, controlled processes and high functioning devices for our customers.
Project Management
CRI has an excellent track record with project management. Each new customer is assigned a dedicated project manager, to ensure effective and timely communication. This includes operating to a plan and schedule, with reporting on deliverables and budget attainment. Project Management is used for new design, design changes and manufacturing transfer programs.
Quality & Regulatory Excellence
CRI is US FDA registered, compliant with 21 CFR Part 820, Quality System Regulation, ISO 13485:2003 certified, and CGMP compliant. CRI holds the European EC Certificate and is licensed with Health Canada. We assist our customers with their regulatory requirements.
Supply Chain Management
CRI's supply chain management is designed to manage and control the most difficult piece for anyone's business. Controlling quality, delivery and responsiveness at the supplier level is not only critical, but is becoming the primary focus for all regulatory bodies, including FDA and ISO13485:2003. Our innovative process provides for excellence to meet not only the regulatory requirements, but to ensure customer's needs are met consistently. This includes a comprehensive feedback system for suppliers and partnering with suppliers for combined excellence and rewards.
Located in Indianapolis, Indiana, CRI is a leading Midwest medical device manufacturer. CRI is 100% owned by a workforce of 120+ employees who participate in the employee stock ownership plan (ESOP). CRI is the parent company of Thomas Medical, a direct distributor of OBGYN disposables and German Stainless Steel Instruments.
Proprietary Products (distributed by Thomas Medical, Inc. Division)
Hystersalpingography (HS, HSG) Catheters, Sono-Inject Catheters, Uterine Manipulators, Loop Electrodes, Endometrial Samplers
Custom Products (Contract Manufacturing)
Gas Sampling Lines (GSL), Electro-Physiology Catheters, Spinal Steerable Catheters, Guidewires, Pacing Leads, Gastrointestinal Devices, Neurological Accessories, High Pressure Contrast Media Injection Lines, Capillary Electroporesis Cartridges, Orthopedic Devices, Custom Kits, Others confidential as requested by customers.