RamSoft delivers quality software and services to its customers, all while meeting regulatory compliance. Learn more about our quality management system, quality policy, and certifications.
Quality management system
Our QMS is audited by a registrar TUV to certify our compliance to MDSAP EN ISO 13485:2016 requirements including Canadian regulations, FDA’s quality system requirements, Brazilian ANVISA and Australian TGA. RamSoft’s quality management system also complies with the European Union Medical Device Regulation.
Quality policy
❝RamSoft is dedicated to continuous innovation and excellence in healthcare technology. We are committed to maintaining and improving the effectiveness of our Quality Management System in compliance with EN ISO 13485 with focus on MDR (EU Medical Device Regulation. Enabling us to deliver software and services that not only meet but exceed the expectations of healthcare professionals while ensuring compliance with applicable regulatory requirements❞.
Vijay Ramanathan, CEO
Regulatory compliance
Health Insurance Portability & Accountability Act
Personal Information Protection and Electronic Documents Act
*Canadian Federal Privacy Law
Our certifications
Ambulatory Phase I and II
* ONC Health IT
Certification Program
Medical Device Class II
License number 97571
Quality assurance policy principles
Executive management will ensure that the quality policy is appropriate to the purpose of the company, and includes a commitment to comply with the requirements of both customers and regulatory authorities and continually improve the effectiveness of the quality management system. The quality policy will provide a framework for establishing and reviewing the policy for adequacy and suitability on a regular basis while ensuring that the quality policy is communicated and understood within the company.
It is important to note that the above quality policy discusses maintaining the quality management system. The use of the word maintaining is taken to mean not only the maintenance of the existing system but ensuring that the system is maintained in accordance with the requirements of applicable regulatory authorities. This policy ensures that RamSoft’s quality management system meets not only the requirements of our users but also all legal requirements in the countries where RamSoft conducts business.
Resources & conformance statements
We take standards compliance very seriously here at RamSoft. That’s why we follow strict quality assurance protocols when developing our products to exchange, integrate, share, and retrieve patient data from 3rd party vendors. View our conformance statements and resources for more information.
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