RYAH Smart Inhaler receives medical device certification for ISO 13485:2016/MDSAP and EN ISO 13485:2016
Both the hardware and digital companion software provide inhalation monitoring, patient feedback, and lab results of therapeutic products with access to objective data to better support therapeutic decisions covered by certifications
TORONTO, ON / ACCESSWIRE / December 8, 2021 / RYAH Group, Inc. (CSE:RYAH) ("RYAH" or the "Company") announced today that its subsidiary, RYAH Medtech, Inc., has received ISO 13485:2016/MDSAP and EN ISO 13485:2016 certification for its proprietary Internet of Things (IoT)-powered dry herb inhaler (the "RYAH Smart Inhaler") and software application associated with the device. This certification is a regulatory requirement and is an international standard that outlines the requirements for a quality management system specific to the medical devices industry.
ISO 13485:2016 is an internationally recognized quality standard to ensure the consistent design, development, production, installation and sale of medical devices that are safe for their intended purposes. To be certified, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer and regulatory requirements. RYAH's ISO 13485:2016/MDSAP certification conforms to the requirements for a quality management system in the countries of Australia and Canada, bringing the RYAH Smart Inhaler one step closer to medical device registration in both jurisdictions. Preceded by two-stage audit completion, these certifications mark a crucial step for the Company's history, as it reflects the international recognition of the design and development, manufacturing, and distribution of smart-inhaler, software application, and accessories.
"This is a monumental achievement for RYAH Group, Inc. and its subsidiary, RYAH Medtech, Inc., as we continue to reimagine plant-based medicine delivery solutions for doctors, clinics and their patients looking for a safe inhalation device with valuable monitoring capabilities," said Gregory Wagner, Chief Executive Officer of the Company. "The approval of the RYAH Smart Inhaler device along with its accompanying software is one of the first of its kind in plant based inhalation devices. It marks a new era for RYAH Group Inc., and is an example of our commitment to utilize data and digital offerings for enabling customized, personalized therapy regimens as an achievable goal for patients and physicians."
Global sales of handheld cannabis medical vaporizers are expected to top US$ 26 billion in 2031. According to a report by Persistence Market Research, the market is estimated to register a compound annual growth rate of close to 22% during the forecast period from 2021 to 2031. The report indicates that "demand for metered vaporizers from European countries is visibly increasing, and the main factors paving way for this demand are growing consumer awareness of metered dosages coupled with initiatives by vaporizers manufacturers to replace non-metered with metered variants."
The RYAH Smart Inhaler is a volume-management device for dry-herb plant based formulations. Paired with a proprietary software application, it allows users to control their dosing regimen, register their usage, and voluntarily provide anonymous data that can further be analyzed and used for regulatory improvements, research and awareness.
About RYAH Group, Inc.
RYAH is a connected device, and big data and technology company focused on valuable predictive analysis in the global medical plant and nutraceutical intake industry. Its robust artificial intelligence platform aggregates and correlates Health Insurance Portability and Accountability Act (HIPAA)-compliant patient data, intended to help doctors and patients personalize plant-based treatments to predict treatment outcomes better. The data collection is relevant for clinics, doctors, dispensaries and pharmaceutical companies, and licensed processors (LPs) to monitor and manage formulation effects on patients and demographics. RYAH gathers deep and insightful data on the complete patient session and formulation lifecycle with a strong intellectual property portfolio. For more information, visit www.ryahgroup.com.
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SOURCE: RYAH Medtech, Inc.