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EndoSoft® Announces ISO 13485:2016 Certification

ISO 13485 Certified badge with gold accents and laurel leaves.

Schenectady, NY – April 1st, 2022 – EndoSoft®, a leading EHR software company, announced today that they received an 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’s 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 in accordance with multiple regulations, including Meaningful Use and Infoway. Keeping consistent with regulatory requirements has been a goal of EndoSoft® since entering the market in 1995, and this certification solidifies that position as the company introduces new solutions into the market.

EndoSoft®’s latest development, Argus®, marries AI with gastroenterology to create the only AI polyp detection and sizing decision support solution on the market today. EndoSoft® also offers EndoVault®, a market-leading multi-specialty EHR with an industry-best 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®

From a solo provider’s practice to large multi-specialty hospital systems, EndoSoft® applications are used by more than 50,000 clinical users worldwide, becoming one of the most trusted names in healthcare technology. EndoSoft®’s offerings include EndoVault®, a market-leading EMR tailored for a multitude of endoscopic specialties, including gastroenterology, ENT, OB/GYN, pathology, orthopedics, cardiology, pain management, pulmonology, oncology, ophthalmology, dermatology, and urology. The software is comprised of modules for procedure documentation, image management, nursing, reporting, scheduling, and inventory management. EndoVault® is also compliant with multiple international standards, including Meaningful Use and IHE.

EndoSoft® is the most advanced EHR on the market today, offering a complete inpatient and ambulatory multi-specialty ONC Health IT Certified EHR.

For an up-to-date record of EndoSoft’s certifications, you can visit our Certifications page. For an overview of information on the ISO 13485 certification, you can visit the ISO’s official site.

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EndoSoft®