Company Profile
Elcam Medical is a world class producer of precision injection-molded disposable medical devices, and a provider of innovative solutions for specialized flow control needs. Elcam supplies its products to the medical industry's leading companies, and today is the premier provider of stopcocks and manifolds to the US and European OEM markets, supplying over 30% of their stopcock needs.
Elcam prides itself on providing the highest level of customized products and support to its OEM customers working collaboratively with them to better serve the medical community with the finest of products, embodying the newest and most cost-effective technologies.
Elcam Medical's precision molding and automated assembly expertise is the foundation of a market leading position in the OEM industry. Many prominent medical device manufacturers benefit from their association with Elcam Medical.
History
Elcam Medical was founded in 1970 as a mold & tool manufacturer, owned and operated by members of Kibbutz BarAm. In 1978, Elcam moved into the injection molding business with its focus on high precision parts, and soon began working with Migada, to develop a hemodialysis bloodline. Migada designed and developed the bloodline sets, while Elcam developed and designed the molds, and produced the components.
Since then Elcam has designed & developed all of its systems to meet the growing needs of the medical industry. In 1981, Elcam started to develop its own product line with the main emphasis on stopcocks, as well as other medical components. In 1982, Elcam began to sell products to the US market. By 1985, Elcam was selling to both U.S. and European companies. In 2001, Elcam established Elcam-Medical Inc. in the U.S.
Elcam is represented in Europe by MedNet GmbH.
Elcam Medical INC.
Elcam Medical now has operations in the U.S. with the establishment in 2005 of an office in Hackensack, NJ. Both Business Development and U.S. Sales are managed through the Hackensack office.
Our mission is to leverage a U.S. presence for the purpose of developing relationships that will provide a stimulus for new product development and position the Elcam Medical sales team closer to our primary market.
Elcam Medical is a fully integrated supplier with design/engineering, partnering and venture capabilities for the identification, creation, manufacture and delivery of flow control devices.
Elcam Product Line
With over 25 years experience in the medical device field, our product line includes a wide range of devices:
Stopcocks & Manifolds – our legacy product line includes standard, high pressure, high flow (large bore) and custom stopcocks. These are strengthened by our new products – closed (swabbable) stopcock, minimally residual volume stopcock (Marvelous), and a complete line of antimicrobial stopcocks.
Needle-less Devices – slit septum devices and cannulas
Pressure monitoring devices - disposable pressure transducer (DPT) and flush device
Interventional Cardiology & Radiology accessories- Elcam has entered the interventional space with the Y-Click device, a Y-Connector for PTCA procedures and the H-Flow valve, a hemostatis flow valve for Angiography.
Auto-Injectors – The Flexi-Q - our new and innovative auto-injector product line for drug delivery that is soon to be commercially available. Flexi-Q is available in both a prefilled version and for drugs in vials.
Elcam Facility
Elcam operates from two facility locations;
BarAm - with 75,000 square feet facility, including 22,000 square feet of 'Class 100,000' clean room, and - as of October 2007 - "Dalton" facility with 32,000 square feet facility including 12,000 feet of 'Class 100,000' clean room.
The facility and land outright on both locations are completely owned by Elcam, enables further expansions when required.
The Elcam facility incorporates the most advanced, computer-controlled manufacturing and quality systems, and has been designed to allow maximum flexibility in producing to customer specifications. This enables Elcam to react within days to new product requests and line changes, and to run prototypes in actual production environments instead of makeshift laboratory settings.
Staff
Elcam has an outstanding team of qualified and experienced employees.
Our employees backgrounds and expertise cover both the technical and the production aspects of precision molding of the demanding standards of the medical industry.
The manufacturing staff, together with specialized consultants to supplement the design and engineering team, ensures that Elcam produces the most reliable and consistent quality products for its clients. The company's development engineers and it's marketing team including the business / product development division-Elcam Medical Inc. are constantly working to develop future products, improve the current designs and look for new markets.
Regulatory & Quality System
Elcam is well aware of its responsibility as a supplier of devices and components to the U.S and European leaders in the medical field.
Elcam meets or exceeds all of the medical industry quality standards. Development, manufacturing, warehousing, documentation and traceability meet FDA's Quality Systems Regulation Title 21 CFR Part 820, and the European Directive 93/42/EEC
Elcam's Quality Management System is ISO 13485 (2003) certified.
Elcam has been successfully audited by the FDA , and has successfully passed an audit by the European notified body. Many of our products products have earned the prestigious CE Mark and are 510(k) cleared.
Equipment
Elcam has always used state-of-the-art equipment to produce its medical devices and components:
EElcam is constantly working with its current suppliers, and is always seeking new ways to improve its product quality and production efficiency, and to maintain its position as a leader in the field.
ISO 13485
ISO 9001 |
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