rHEALTH Attains ISO 13485 Certification
BEDFORD, Mass., April 22, 2020 – rHEALTH LLC, a Diagnose Yourself, Anywhere™ company, announced today that it has received ISO 13485:2016 certification for the design, development, production, distribution, and servicing of in vitro diagnostic devices (IVD), kits, reagents, analyzers, and software. Simultaneously, rHEALTH unveiled the expansion of its Bedford, MA facility to 22,000 square feet, inspected as part of the certification process, to support its growing commercial operations.
The International Organization for Standardization (ISO) is the world’s leading developer of quality standards. ISO 13485:2016 sets the globally accepted benchmark for medical device design and manufacturing. Certification is awarded following a rigorous two-stage audit by an external Notified Body, confirming compliance with the highest quality and safety standards.
The audit was conducted at rHEALTH’s newly expanded diagnostics facility, engineered to meet the exacting requirements of its IVD products. The state-of-the-art space includes a full BL2 laboratory, clean hoods, energy-efficient systems, electrostatic discharge safe manufacturing areas, laser-safe dark rooms, backup power, and additional room for future growth.
Eugene Chan, MD, Chairman and CEO of rHEALTH, said:
"These milestones significantly enhance our ability to meet global commercial demands. The ISO certification reflects the rigorous quality and safety standards we uphold every day. Our new facility embodies the precision, reproducibility, and operational excellence that are core to our mission of delivering reliable diagnostics anywhere."
About rHEALTH®
rHEALTH is a digital health solutions company focused on developing and commercializing its Diagnose Yourself, Anywhere™ technology. Its innovations include the rHEALTH diagnostic platform, enabling diverse laboratory test classes from a single small volume blood sample; the SKYE Sensor, a wireless wearable delivering comprehensive real-time vitals monitoring; and CHAS, a user-friendly mobile application. For more information, visit www.rhealth.com.
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