Press Release (ePRNews.com) - SAN FRANCISCO - Dec 07, 2017 - Calimex USA, a leader in regulated software development and systems integrator, is pleased to announce our company’s success in helping Macopharma receive FDA 510(k) clearance on Nov. 9, 2017 for its MacoPress Smart and DMS Plus – BK170085. Calimex USA is committed to supporting Macopharma interface and implement the MacoPress Smart and DMS Plus to any Blood Establishment Computer Software (BECS).
The MacoPress Smart functions as an automated press, clamp, and sealer to separate the blood components from the centrifuged blood bag systems. By means of the controlled movement of a press used to press the bag of centrifuged whole blood, a network of clamps fitted with sealer heads, three or more weighing scales (depends by the chosen configuration) and a series of optical sensors, MPS automatically and accurately extracts and transfers blood fractions from the main bag to the satellite bags. With the use of the DMS Plus software, the separation procedures can be programmed to collect data of manufacturer components that can then be recorded, stored and analyzed.
Calimex USA provides FDA-related Regulatory and Compliance support services to a number of local and global corporations. Calimex is also the information technology arm of Macopharma in the United States providing software interface, integration and consulting solutions. Macopharma distributes globally several of Calimex’s FDA 510(k) cleared software medical devices such as Picture-ID or eDHQ www.Picture-ID.net, eOrders www.eBloodOrders.com and the new copyrighted and patented donor recruitment accelerator called DonorHERO www.eDonorHero.com. Together Calimex and Macopharma will synergize the products and services offerings to their customers, increasing the effectiveness and efficiencies of delivering top products and services to blood centers, hospitals and laboratories.
About Calimex USA
Calimex USA Corporation is an American information technology company specializing in the regulated healthcare environment. It is a leading provider of specialized healthcare solutions with over three decades of experience in developing and delivering innovative solutions designed to ensure the highest level of safety, security, efficacy, effectiveness and efficiency. Calimex takes complex clinical — and often painfully inefficient processes — and automates them for positive return on investments (ROI). Calimex is a medical devices manufacturer (software) and owns several FDA 510 (k) approved software medical devices. www.calimex.net
About Macopharma USA
Macopharma USA is the American subsidiary of Macopharma headquartered in France. Macopharma is a leading global player in transfusion and biotherapy systems. Macopharma works to design innovative solutions and quality products that are effective in meeting the needs of both patients and healthcare providers. Every day across the world, Macopharma employees are dedicated to making therapeutic practices easier, better and safer. That is what Macopharma means by their slogan “Designed for life.” Macopharma has over 2,300 employees in four production facilities, 16 commercial subsidiaries, two branch offices, with 50 distributors covering over 100 countries. Its values cover Professionalism, Performance, Motivation and Solidarity. www.macopharmausa.com.
Sam Waran – Calimex USA Corporation
Caroline Hernu – Macopharma USA Source :
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Calimex USA Corporation