Author: Smile CDR
ISO 13485:2016 audit demonstrates company’s commitment to high-quality design, production, installation and servicing of the Smile CDR platform
TORONTO, ONTARIO – January 5, 2022- 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.
For more information, check out the full press release.
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