RamSoft delivers quality software and services to its customers, all while meeting regulatory compliance. Learn more about our Quality Management System, Quality Policy, and the certifications that govern how we build, ship, and maintain our products.
Quality Management System
RamSoft's Quality Management System (QMS) is audited by TÜV SÜD as the certifying registrar to verify compliance with MDSAP EN ISO 13485:2016 requirements. This audit covers regulatory expectations across the major medical-device jurisdictions in which our customers operate:
In addition, RamSoft's QMS complies with the European Union Medical Device Regulation (EU MDR 2017/745).
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.
Vijay Ramanathan
CEO, RamSoft
This policy is reviewed regularly by executive management, communicated throughout the organization, and used as the framework against which our quality objectives are set and measured.
Regulatory Compliance
RamSoft's products and services meet the privacy and security obligations of the major healthcare jurisdictions our customers serve:
Our Certifications
RamSoft maintains the following third-party certifications across quality, security, and healthcare interoperability:
Quality Assurance Policy Principles
Executive management is responsible for ensuring that the quality policy:
- Is appropriate to the purpose of the organization;
- Includes a commitment to comply with regulatory requirements and to maintain the effectiveness of the QMS;
- Provides a framework for establishing and reviewing quality objectives;
- Is communicated and understood at all levels of the organization;
- Is reviewed for continuing suitability on a regular basis.
The Quality Management System undergoes continuous improvement through internal audits, management reviews, customer feedback, and corrective and preventive actions (CAPA).
Resources & Conformance Statements
RamSoft follows strict quality protocols when developing products to exchange, integrate, share, and retrieve patient data from third-party vendors. Conformance statements and detailed compliance documentation are available on request from the Customer Portal or via your account team.
Contact Us
For questions about RamSoft's compliance program, conformance statements, or certification details, reach out to our team:
- Toronto HQ: 8 King St E #208, Toronto, Ontario M5C 1B5 · +1 888.343.9146 · contactsales@ramsoft.com
- USA Office: 131 Continental Drive, Suite 301, Newark, Delaware 19713 · +1 888.343.9146
- India Office: IndiQube Ascent, Municipal No. 420, Koramangala 4-B Block, Bengaluru 560034
