Elcam News | December 2022

Joint Validation & Verification

Over the past few years, it has become evident that medical device companies are looking for ways to expedite approval processes of new designs. A highly effective process for Joint Validation & Verification (V&V) activities is a customized service offered by Elcam in order to meet this need and remove the burden from the medical device provider. The process complies with ISO 13845 standard requirements.

It is well known that when a medical device manufacturer sources certain critical components from a supplier, the component must comply with specifications and be validated for a certain application. This validation is a documented guarantee that a product can be manufactured reliably and repeatedly to satisfy a predetermined level of quality.

Many companies invest meticulous efforts and valuable time in product or component acceptance activities. The traditional V&V approach in sourcing a new or substitute component is usually done in series of stages on both sides – component manufacturer and OEM.

A mutual V&V program will reduce the work load of the medical device provider.  This service that is offered by Elcam can significantly accelerate the approval process and time to market of the end product in addition to saving the provider a significant amount of resources.

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Elcam strives to enhance patients’ and medical teams’ safety and treatment experience. Following you will find two excellent examples of new and improved products that were designed with these intentions in mind.

A-Tap™

The new and innovative A-Tap™ by Elcam was designed to facilitate intra-articular injections by allowing aspiration and injection to be done with the same device, thereby reducing the number of steps for practitioners and improving the patient treatment experience.

“A-Tap™ makes a cumbersome procedure easier for both the practitioner and the patient” says Dr. Michael Wilmink, MD, Orthopedic Surgeons

By allowing aspiration and injection to be carried out with the same device, the A-Tap™ cuts down the number of steps for practitioners and reduces procedure time.

Enabling two procedures with one needlestick and minimizing needle movement, this new device can greatly improve the patients’ treatment experience.

Furthermore, the A-Tap™ enhances treatment accuracy and efficacy with the confirmation of needle tip position by aspiration, which supports best practice recommendations (ACSM’s Sports Medicine: A Comprehensive Review 2012 I Francis G. O’Connor I pg.126).

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SafePort™ Manifold

The SafePort™ is an improved function manifold with patented dual flow option innovative side-port valves designed to improve safety in anesthesia and ICU applications. The two flow options are controlled by a simple 90⁰ turn of the handle: Accessible for two-way free flow or one way pressure activation.

The SafePort is now available with a new improved design in which the handles are injected using a new technology of 2C molding which guarantees improved accuracy and reliability.

As with the previous design , the new SafePort™ is also available as a closed system with integrated Swabbable Luer Activated Valves, for minimizing leakages and exposure to air and contamination

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Team news

Tomer Gil has replaced David Landspurg as General Manager of Elcam Medical Inc. Tomer has been part of the Elcam team for 20 years and recently relocated to the US to empower the US business development activities, a role which he will continue to uphold, together with managing our US office in Hackensack New Jersy. Join us in wishing him a lot of success in his new position.

 

Yolanda Roman has joined the Elcam Medical Inc. team in New Jersey on July 2022 in the role of Customer Service Specialist. Her background is in Customer Service, Management and Purchasing with over 30 years of experience.
Yolanda told us: “I am excited to have been given this opportunity to work here at Elcam with a very gifted and welcoming team. I look forward to growing in the position and bringing my skill set from my years of experience in Customer Service”.
Welcome Yolanda!