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EndoSoft Announces ISO 13485:2016 Certification

EndoSoft, a leading health IT company, announced today that they received ISO 13485:2016 Quality Management System Certification for the design, development, integration and support of Electronic Health Record (EHR) and Artificial Intelligence (AI) software products (Registered by SRI Quality System Registrar). This certification verifies industry quality system requirements while emphasizing safety and efficacy in medical device development.

“This certification demonstrates our commitment to the highest quality standards in product development and services,” said Rakesh Madan, president and CEO of EndoSoft. “We make every effort to continually meet client and regulatory expectations.”

EndoSoft has been a long-standing member of the health IT industry and has been certified over multiple regulations, including Meaningful Use and Infoway. Keeping consistent with regulatory requirements has been a pillar of EndoSoft since entering the market in 1995. This certification solidifies that position as the company introduces new solutions into the market.

EndoSoft’s latest development, Argus, marries Artificial Intelligence with the field of Gastroenterology creating the only AI Polyp Detection and Sizing Decision Support solution on the market today. EndoSoft also offers EndoVault, a market leading Specialty Specific EHR with an industry leading data migration tool that bridges the gap of new system integration.

About Argus®

Argus® is an AI solution powered by EndoSoft® that integrates with all Electronic Health Record (EHR) systems, endoscopes, and video processors. Argus® is automatically launched at the start of the endoscopy procedure to aid in the detection and sizing of polyps within the GI tract. Argus® assists clinicians with the detection of polyps and other luminal abnormalities. Argus® utilizes artificial intelligence (AI) and deep machine learning all while capturing images simultaneously, in real time.

About EndoSoft®

With over 50,000 clinical users worldwide and over 25 years of expertise, EndoSoft® has achieved a leadership position and a reputation for excellence and quality in the healthcare industry. EndoSoft® offers a multitude of specialties to meet the needs of clinicians in Gastrointestinal Endoscopy, ENT, OB/GYN, Pathology, Orthopedics, Cardiology, Pain Management, Pulmonology, Oncology, Ophthalmology, Dermatology, and Urology. Other software applications available are Nursing, Infusion, Scheduling, Reprocessing and Inventory Management modules.

EndoSoft® is the most advanced Electronic Health Record on the market today, boasting the most complete Inpatient and Outpatient multi-specialty Health IT Certified EHR by the Office of National Coordination.

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Kathleen Schechner

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