MedicaMetrix Receives ISO 13485 Certification from GMED for its Quality Management System

This certification establishes that the company’s quality management system complies with the requirements of the international standards organization.

BOSTON, MASSACHUSETTS (September 29, 2021) – MedicaMetrix, Inc. announced the successful certification of its facilities in the U.S. and India under ISO 13485:2016 by GMED, a French Notified Body.

This action certifies that the quality management system developed by MedicaMetrix, Inc. further validates the superior manufacturing and quality control systems the company has perfected and is now using routinely.

MedicaMetrix plans to apply this certification to multiple products including ProstaMetrixTM, the company’s prostate volume measuring device, and SureSetTM, a peripheral intravenous securement device.

“This is another important milestone for MedicaMetrix,” Christopher LaFarge, COO of MedicaMetrix stated. “Receiving ISO 13485 Certification from a Notified Body is a critical step towards establishing a world-class, medical device manufacturing capability in the U.S. and India.”

This is another positive step for the company as it continues to execute its strategy of international sales and distribution of its family of brands and products.

About MedicaMetrix
MedicaMetrix develops innovative medical technologies and device solutions that transform the healthcare status quo, leading to better medical outcomes, streamlined care and an enhanced patient experience.

MedicaMetrix is leading the development of a new paradigm that transforms the diagnosis, treatment, and management of prostate health by filling the gap between PSA testing and biopsies and surgery.

MedicaMetrix plans to continue to acquire and develop additional, new medical devices with the goal to bring them to market rapidly by leveraging its production facilities in the U.S. and India.

Cautionary Statements Concerning Forward-Looking Statements
Some of the statements in this press release may be forward-looking statements or statements of future expectations based on currently available information. Such statements are naturally subject to risks and uncertainties. Factors such as the development of general economic conditions, future market conditions, unusual catastrophic loss events, changes in the capital markets and other circumstances may cause the actual events or results to be materially different from those anticipated by such statements. MedicaMetrix Inc. does not make any representation or warranty, express or implied, as to the accuracy, completeness, or updated status of such statements. Therefore, in no case whatsoever will MedicaMetrix Inc. and its affiliate companies be liable to anyone for any decision made or action taken in conjunction with the information and/or statements in this press release or for any related damages.

MedicaMetrix, Inc.

Source: MedicaMetrix, Inc.
Released September 29, 2021

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