Certification conforms to worldwide standard for medical device quality and together with the expansion, allows rHEALTH to meet its commercial objectives
BEDFORD, Mass., April 22, 2020 – rHEALTH LLC, a Diagnose Yourself, AnywhereTM company, today announced that it has received ISO 13485:2016 certification for the design and development, production and distribution, and servicing of in vitro diagnostic devices (IVD), kits, reagents, analyzers, and software. Concurrently, it announced expansion to a 22,000 square feet facility in Bedford, MA, which was inspected during the certification process and will support its commercial operations.
The International Organization for Standardization (ISO) is the world’s largest developer of quality standards. The ISO 13485:2016 Quality Management Standard for Medical Devices is the accepted standard for the design and manufacture of medical devices. The certification is performed by an external Notified Body which performs a two-staged multiple day comprehensive quality system audit to ensure quality and safety standards are met.
The audit was performed at the rHEALTH’s new state-of-art diagnostics facility which was designed and engineered to meet the exacting standards of the Company’s IVD products. The facility includes the latest infrastructure for a high-performing operation, including a full BL2 laboratory, clean hoods, energy efficient systems, electrostatic discharge safe manufacturing areas, laser safety dark rooms, backup power, and additional square footage for expansion.
Eugene Chan, MD, Chairman and CEO of rHEALTH commented: “Together, these new developments give us significant capability to meet our global commercial demands. The certification attests to the high bar of quality and safety our company must meet on a daily basis. The facility supports the rigorous nature of our work. These reflect our organizational culture which has embraced accuracy and reproducibility as being paramount to any diagnostic test.”
rHEALTH is a company focused on the development and commercialization of its Diagnose Yourself, AnywhereTM technology. rHEALTH’s innovations consists of the rHEALTH diagnostic platform, which enables diverse laboratory test classes in a single small volume blood sample intended as a point-of-care solution, the SKYE Sensor, a wireless wearable providing comprehensive real-time vitals monitoring and CHAS, a user-friendly mobile application. For more information, visit www.rhealth.com.
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