MedicaMetrix achieves important milestone on its path to commercialize ProstaMetrix and SureSet medical devices
BOSTON, MASSACHUSETTS (September 9, 2020) – MedicaMetrix, LLC, a prostate disease management and securement devices medical device company announced today that the company received ISO 13485:2016 certification for Medical Device and Quality Management Systems. This ISO certification indicates that the company’s quality management system meets the most current regulatory requirements specific to the medical device industry. “We are very proud of this certification and it demonstrates the commitment of our global team to quality, and to meeting customer and international regulatory expectations,” said Satish Vankayalapati, Co-Founder and Chairman of MedicaMetrix.
“This certification is further evidence of our unwavering commitment to quality and enables MedicaMetrix to continue to develop ProstaMetrix and SureSet devices in compliance with the highest standards for safety, product performance and reliability,” said Robert Rudelius, CEO for MedicaMetrix. “Maintaining a world-class quality management system is a key goal for MedicaMetrix.”
ISO 13485:2016 is an internationally recognized quality standard for a quality system to ensure customer and regulatory requirements are consistently met throughout the lifecycle of the medical device product. “This certification represents an important milestone for our company and reflects our rigorous and risk-based approach to development and commercialization,” said Christopher LaFarge, MedicaMetrix’ COO and Global Head of Quality.
MedicaMetrix develops innovative technologies and device solutions that transform the healthcare status quo, leading to better medical outcomes, streamlined care and enhanced patient experience.
We are leading the development of a new paradigm that transforms the diagnosis, treatment, and management of prostate health by filling the gap between PSA1 testing and imaging / biopsies. The ProstaMetrix system is a minimally invasive medical device designed to accurately measure the volume of the prostate gland early in the diagnostic process. ProstaMetrix helps physicians assess a patient’s prostate status to better plan and monitor diagnostic procedures, treatments, drug therapies, and guide recommendations for active surveillance versus prostate biopsies.
MedicaMetrix is planning on releasing a number of devices including our SureSet™ Securement device, which secures the catheter hub and infusion tube with a single site bandage and organizes the tubing for easy access and removal. This one simple device streamlines infusion set-up, allows safe and easy access, while reducing variation and improve safety.
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