Medical Device Qualified Supplier Directory
INTERTECH DEVELOPMENT COMPANY Company Profile
Qualifications: ISO 13485, ISO 9001, FDA Registered, CGMP Certified, Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows
Markets Supplied: North America, Europe, Worldwide
InterTech Development Company provides medical device and medical product manufacturers with turnkey leak testing solutions and superior custom leak detector instrumentation that ensures ISO 13485:2003, and all FDA requirements for GMP.
Unlike off-the-shelf mass produced leak detectors, InterTech’s patented nondestructive testing instrumentation for FDA-regulated manufacturers is optimized for GMP manufacturing environments, and proven to be the most cost-effective test technology for a wide range of medical devices and medical products such as catheters, dialysis equipment, medical check valves, syringes, laparoscopic instruments, IV bags, oxygen regulators, implanted medical devices, artificial valves, home care technology, and more.
InterTech’s testing applications laboratory designs turnkey test solutions—for prototype development and for cost-effective assembly & test operations—both fully automated or in semi-automated production lines in globally distributed manufacturing facilities. InterTech's worldwide organization has hubs in North America, Europe, and Asia and service engineers are on call in the USA, France, Germany, Korea, and China for installation, assistance and training.
InterTech Development Company is ISO 9001 registered and InterTech’s Calibration Laboratory is ISO 17025 accredited.
InterTech’s multi-channel leak detectors designed for GMP facilities can be used for pressure decay testing, differential pressure decay testing, mass flow leak testing, burst testing, obstruction testing and detection of blockages in both rigid and flexible medical devices or device components, and testing of flow integrity.
Detailed engineering analyses of specific application requirements and best-match test technology (maintaining GMP quality standards at the lowest cost) are available from InterTech’s Testing Applications Laboratory for no charge.
The InterTech Development Unique Device Identifier (UDI) System, which integrates bar coding, scan and software tracking of each part and batch, including all leak test, functional test and lifecycle test data related to each component facilitates FDA CAPA quality programs, FDA reporting requirements, and anticipates the FDA 2013 final UDI ruling. All InterTech test solutions feature proven software that tightly integrates high speed data acquisition to control systems, minimizing needs for test stands, especially important to keeping down production costs of disposable medical products.
InterTech’s turnkey test solutions have consistently lowered medical device, medical product testing costs by 25% or more. To achieve these cost-reductions and maintain GMP standards, InterTech brings an encyclopedic knowledgebase of test fixture design and a wide array of patented leak test technology including InterTech’s Advanced Mass Flow Sensor; Bias Flow Leak Testing; CalVal (electronic technology for self-calibration and automatic validation of leak testing); CalMaster (user- adjustable, hand-held, electronic alternative that displays leak or flow rate continuously in digital read-out format); Hydraulic Fluid/Dry Air Testing and a Pneumatic Extending Clamp (automated high pressure clamps to shorten sealing times and test times).
Descriptions of sample InterTech turnkey test solutions for the medical device industry can be found at http://www.intertechdevelopment.com/solution_category_detail.cgi?id_num=2.