October 2, 2022
  • October 2, 2022

Smile CDR receives quality management certification for its flagship product

By on January 5, 2022 0

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TORONTO, Jan. 05, 2022 (GLOBE NEWSWIRE) – Smile CDR Inc., a leading healthcare data and integration company, has achieved 13485: 2016 Quality Management System certification from the International Organization for Standardization (ISO) for medical devices for its namesake platform, Smile CDR, validating its commitment to create high quality health information technology (IT) programs. This certification confirms that the company’s software development processes are secure and that Smile CDR has consistent and repeatable processes in place to deliver care in any clinical environment.

“Our vision of #BetterGlobalhealth drives us to ensure that our products are suitable for all aspects of healthcare,” said James Agnew, CTO, Smile CDR. “This certification proves that as new and different use cases are discovered, we are not only able to quickly develop a solution, but also to do it in the safest way possible without sacrificing quality.”

ISO 13485: 2016 is used by organizations and certification bodies to assess the design, production, installation and maintenance of medical devices and associated services. Although not a requirement of the standard, third-party certification can demonstrate to regulators that a company has met the requirements of the standard. Smile CDR passed the rigorous certification process by demonstrating its superior software, training and product purchasing processes, and performing risk management assessments in support of its clinical data repository platform. (CDR).

“A notoriously difficult certification to achieve, this achievement not only demonstrates our company’s commitment to high-quality programs, but also opens the door to future market expansion and significantly lessens the burden of obtaining future ISO certifications. “Said Luis de Barros, Privacy Officer. and security officer at Smile CDR. “I am very proud of our team for achieving such a level of process management and for having the discipline to create better value-driven software. ”

The certification process was initiated by Smile CDR in early 2020 in collaboration with TELUS Health and IDENTOS. This is the company’s second ISO certification since September 2021, when they were obtained ISO / IEC 27001: 2013 certification for information security management.

About Smile CDR

Smile CDR Inc. is a healthcare technology company that reduces barriers between information and care for those who consume or provide healthcare services with complex information systems. We’re on a mission to make it easier for healthcare organizations of all sizes to take control of their data and quickly deliver interoperable applications. Our data and integration platform includes a comprehensive clinical data repository built around the HL7® FHIR® standard used to store health records and supports all FHIR resources. As a strategic partner, our products, professional services, and sales support give organizations the edge they need to enable interoperability within their healthcare systems using a standards-based solution that leverages Part of the world’s most proven FHIR implementation. For more information visit: www.smilecdr.com.


Media contacts

Lucy Railton Marketing Director Smile CDR Inc. (800) 683-1318 x 712[email protected]

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Source: Smile CDR Inc.