Your Only Source of Clinical OEM Solutions

Seamlessly providing high quality disposable flow control medical devices and solutions for the medical OEM industry

Elcam’s Product Development Process

  • Ideas
  • Design & Development
  • Manufacturing Engineering
  • Manufacturing
  • QA & Regulatory
  • Marketing & Sales
  • Latest Solutions

Ideas

We at Elcam Medical, by close cooperation with OEM customers, key clinicians and inventors are exploring the medical market on a day to day basis. We are acquainted and committed to medical market needs, trends, benchmarks and are providing high quality feasible evaluations.

Design & Development

Our Design and Development Engineering team through its vast experience, creativity and application of up to date engineering tools, is qualified to give the best advice and support in cost-effective design, raw material, product features and specifications, in accordance with the design control requirements of 21 CFR part 820.30 and ISO 13845 : 2016.

Manufacturing Engineering

Elcam Medical's initial capabilities are rooted in manufacturing, injection molding and automatic assembly. Our Process Engineering team transforms prototypes into manufacturable, cost-effective, validated devices, as well as developing and adjusting specially designed production lines in our Class 8 (ISO 14644) clean rooms.

Manufacturing

State of the art tooling, multi-cavity and 2C (two-components) molds in versatile injection machines produce the parts, which are then assembled in our fully automated assembly lines, under strict Quality Control of the entire process all the way down to the warehouse. The barcode identified lots are stored and dispatched by computerized logistics - providing full traceability for each product delivered to the customer.

QA & Regulatory

Our robust QA and Regulatory system provides confidence in design, manufacturing and distributing cleared/approved, reliable devices that comply with relevant regulatory requirements and strictest standards of the medical device industry. Elcam is committed to working according to all applicable laws and regulations and our quality management system aims to maintain its ISO 13485 certification and compliance with 21 CFR 820 throughout the products life cycle.

Marketing & Sales

Through our extended marketing system, Elcam Medical's Marketing & Sales teams at the Headquarters and at our offices in the US, Europe, the Far East and in South America, promote and distribute our products worldwide. Elcam markets their products through 160 companies in the US, 230 in Europe, and over 550 companies worldwide.

Latest Solutions

Elcam Medical has already successfully implemented this model for our customers and their products, covering a wide range of medical areas and in multiple technologies. Examples of such products are the Disposable Integrated Pressure Transducer, the SafePort™ Manifold and our Marvelous™ Stopcock. Elcam is developing other technologies to be marketed with user-needs in mind, with a special emphasis on enhanced patient & caregiver safety.

Innovation and Continuous Development

Elcam Medical develops, manufactures and sells innovative medical systems, devices and components for IV Therapy, Patient Monitoring, Dialysis and Interventional Cardiology & Radiology applications. Our products promote several patient and caregiver safety issues, such as minimizing bloodstream infections, reducing the likelihood of tubing misconnections and disconnections and protecting healthcare workers from exposure to infectious diseases or hazardous drugs.

Care for our customers and their success drives our innovation.
We innovate based on our customers’ needs in order to provide real solutions to real problems, and to offer a competitive advantage for our customers.

 

 

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Quality Assurance

Elcam Medical is experienced in working under tight deadlines, without compromising quality. Elcam is committed to working according to all applicable laws and regulations, and operates in compliance with 21 CFR 820 and  ISO 13485:2016 throughout the products life cycle. This includes R&D activities, production, sales, marketing, and post market surveillance, for continuous improvement in product quality, product safety and effectiveness and customer service. Elcam acts to maintain the effectiveness of its quality management system. Most of our products are 510(k) cleared. Our stopcock and Manifolds are CE approved for non-sterile products.

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Your source of medical OEM solutions


Elcam provides high quality single-use medical devices and solutions intended for flow control applications for the medical OEM industry, providing the needed components for critical care sets.


Elcam is a medical OEM industry leader and expert in the medical devices markets. Elcam believes that the small details make a difference and strives to provide the highest quality components and the support needed for building the best final devices.

 

Elcam expertise lays not only in producing products, but also in providing engineering and regulatory support across the product's life cycle, from design and development, through manufacturing and registration, up to launching and post marketing.  

 

This is exactly what makes Elcam Medical your optimal OEM partner and the best source for your medical OEM solutions.