Certification
“Certified for quality. Trusted for excellence”
Ambalsoft Infotech Private Limited is ISO 9001:2015 certified, reflecting our commitment to quality, reliability, and customer satisfaction. Our certified scope includes clinic management systems, medical image capturing and reporting software, and advanced imaging technologies such as DICOM, HD, 3D, and UHD 4K.
This document is a Certificate of CE (MDR) Notification, which indicates that Amstermed BV is acting as the Authorised Representative for AMBALSOFT INFOTECH PRIVATE LIMITED for placing your medical devices (listed in Annex A of the certificate) on the European Union (EU) and European Economic Area (EEA) market, ensuring compliance with the Medical Device Regulation (MDR) 2017/745.
AMBALSOFT INFOTECH PRIVATE LIMITED is proud to announce that our Medical Device Quality Management System has been assessed and found to conform to the requirements of ISO 13485:2016.
AMBALSOFT INFOTECH PRIVATE LIMITED is a Udyam Registered MSME (Micro, Small, and Medium Enterprise) recognized by the Government of India, affirming our commitment to economic growth and national enterprise development.
Our products are registered with the Central Drugs Standard Control Organization (CDSCO), ensuring full compliance with India’s medical device regulations. This certification confirms that our devices meet the required standards for safety, quality, and performance, and are approved for use and distribution across India.
Our medical software solutions are FDA registered, ensuring they meet the highest standards of safety, accuracy, and regulatory compliance. This registration reflects our commitment to delivering reliable, high-quality products trusted by healthcare professionals worldwide.
Ambalsoft Infotech Private Limited is recognized by the Federation of India for adhering to national standards of quality, integrity, and professionalism in the development of medical software solutions. This recognition reflects our continuous commitment to contributing to India’s growing healthcare and technology ecosystem.
Our medical software solutions are FDA registered, ensuring they meet the highest standards of safety, accuracy, and regulatory compliance. This registration reflects our commitment to delivering reliable, high-quality products trusted by healthcare professionals worldwide.
Ambalsoft Infotech Private Limited is a proud member of the Madras Chamber of Commerce & Industry (MCCI). This membership reflects our commitment to maintaining high business standards, fostering industry collaboration, and contributing to India’s growing technological and healthcare ecosystem.
Ambalsoft Infotech Private Limited is D-U-N-S® registered, ensuring global recognition and credibility in business identification and verification. This registration strengthens our trustworthiness and reflects our commitment to transparent and responsible business operations.
AMBALSOFT INFOTECH PRIVATE LIMITED was an officially recognized member of the Microsoft BizSpark program.
This program granted us access to leading-edge Microsoft development tools and cloud services, demonstrating our foundation in world-class, scalable technology and our commitment to building our innovative software solutions on a reliable, enterprise-grade platform.