Smile CDR Receives Quality Management Certification for Flagship Product

ISO 13485:2016 audit demonstrates company's commitment to high-quality design, production, installation and servicing of the Smile CDR platform

Smile CDR Inc., a leading health data and integration company, has achieved the International Organization for Standardization (ISO) 13485:2016 quality management system certification for medical devices for its namesake platform, Smile CDR, validating its commitment to building high-quality health information technology (IT) programs. This certification confirms the company's software development processes are secure, and that Smile CDR has consistent, reproducible processes in place to provide care in any clinical setting.

"Our vision of #BetterGlobalhealth drives us to ensure our products are attuned to every aspect of healthcare," said James Agnew, chief technology officer, Smile CDR. "This certification proves that as new and different use cases are discovered, we are not only capable of rapidly developing a solution but doing it as safely as possible without sacrificing quality."

ISO 13485:2016 is used by organizations and certification bodies to evaluate the design, production, installation and servicing of medical devices and related services. While 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 by conducting risk management assessments in support of its clinical data repository (CDR) platform. 

"A notoriously difficult certification to obtain, this achievement not only demonstrates our company's commitment to high-quality programs, but also opens the door to future market expansion and significantly eases the burden of achieving future ISO certifications," said Luis de Barros, chief privacy and security officer at Smile CDR. "I'm very proud of our team for achieving such a high caliber of process management and for having the discipline to build a better software focused on the value of quality." 

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

About Smile CDR

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


Media Contacts

Lucy Railton
Director of Marketing
Smile CDR Inc.
(800) 683-1318 x 712

Source: Smile CDR


Categories: Healthcare Technology

Tags: announcement, certification, Standardization

About Smile CDR Inc.

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Smile CDR's mission is to make it easy for health organizations of all types to provide #BetterGlobalHealth through secure, fast, and interoperable health data sharing.

Media Contact: Lucy Railton | (800) 683-1318 x 712 |

Smile CDR Inc.
622 College Street (Suite 401)
Toronto, Ontario M6G 1B4