Faciox Inc. brings together professionals with backgrounds in medicine and engineering, dedicated to leveraging our combined expertise to benefit Taiwan and the world through premium medical devices. Understanding that home-based care is preferred by most patients, we help them achieve their ideal lifestyle by creating UPOC, a high-specification, medical-grade oxygen concentrator, proudly Made in Taiwan (MIT). From its underlying gas-flow modeling to its overall product architecture, UPOC is fully self-developed and manufactured in-house, aiming to drive wider adoption and pioneer a new concept of home care in Taiwan. The UPOC Oxygen Concentrator OC505 utilizes advanced molecular sieves to separate oxygen from nitrogen in the air, delivering highly concentrated therapeutic oxygen with a maximum flow rate of 5 L/min. Designed for easy operation, it allows users to breathe effortlessly. For added assurance, the OC505 holds two independent third-party certifications: it has passed SGS antibacterial casing testing and has been awarded the SNQ (Symbol of National Quality) certification. Core Values — User-friendly: Intuitive design and effortless operation. Professional: Products engineered with expert medical knowledge. Oxygenate: Uncompromised, premium oxygen supply quality. Commitment: A dedicated promise to deliver the best customer service.
Domestic medical device manufacturer Quality Management System (QMS).
Oxygen Concentrator Product Standard ISO 80601-2-69.
Oxygen Concentrator Product Safety Standards: IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020.
Oxygen Concentrator Electromagnetic Compatibility (EMC): IEC/EN 60601-1-2:2007; Emissions: CISPR 11:2015+A1:2016, IEC 61000-3-2:2018, IEC 61000-3-3:2013+A1:2017; Immunity: IEC 61000-4-2:2008, IEC 61000-4-3:2020, IEC 61000-4-4:2012, IEC 61000-4-5:2014+A1:2017, IEC 61000-4-6:2013, IEC 61000-4-8:2009, IEC 61000-4-11:2020.
i. Lead the manufacturing function in setting product quality targets (including component-level quality), maintaining quality records and statistics, conducting nonconformance analysis, and implementing corrective and preventive actions (CAPA), with periodic or real-time reporting.
ii. Evaluate and identify production issues and adverse events, and report them immediately to enable prompt risk assessment, control, and corrective measures.
iii. Promote and take responsibility for executing the Quality Management Plan (QMP), and regularly or instantly report execution results and identified issues.
Description of Non-compliance Records Within Three Years: None.
Product HW/SW (Design, Deployment & Maintenance)
Product Design and Development. Faciox's R&D balances market needs and risk control to meet user expectations and medical device regulations: Feasibility — the marketing team conducts user, competitor, and SWOT analyses, and R&D assesses technical feasibility. Specifications & Risk — define product specifications and perform risk management aligned with domestic and global regulations. Prototyping — the marketing team simulates user scenarios to validate and optimize prototypes until finalized. Production — R&D sets trial workflows and QC methods, then transfers successful data to mass production.
Software Deployment and Maintenance. Development & Verification — follow the V-Model for software development, testing, and validation per QMS guidelines. Updates — manage all software maintenance and version updates strictly through ECR/ECN procedures.
Faciox's QMS Risk Management Report conducts risk assessment as follows:
Report on the medical device risk assessment process — covering Risk Identification, Risk Estimation, Risk Evaluation, Risk Control, Risk Acceptance, residual risk assessment, and overall residual risk assessment. This report evaluates the risks arising from the device's potential hazards.
Scope of risk assessment: risk management shall cover the device's entire lifecycle, planned according to the product realization process and its characteristics.
Device attributes: a non-implantable medical electrical (active/powered) device and a home-use medical device (operated by non-professional users)
Post-Market Surveillance (PMS) Management Faciox runs this procedure to monitor and improve safety and clinical efficacy. Data (complaints, advisories, regulatory notices, satisfaction) are aggregated, and negative feedback is integrated into risk management.
Sales & Marketing — Tracks market and user data (collect, analyze, record, report): A. Market: User feedback, complaints, regulatory updates, clinical literature. B. Adverse Events: Recalls, advisories, competitor issues; report to authorities as required. C. Users: Complaints, online reviews, and user experiences. D. Competitors: Specs, safety data, and product improvements. E. Service: Customer support operational data. F. Literature: Manage promotions to prevent user misuse risks.
Manufacturing — Maintains post-launch compliance and improvements: A. Standards: Track industry/regulatory updates and drive improvements. B. Feedback: Review market feedback collected by Sales. C. Risks: Assess safety/misuse risks in new markets or user groups. D. Risk/Trends: Continuous risk analysis, long-term performance, and side effects.
Quality Assurance (QA) — Collaborates with Manufacturing on quality control and real-time response: i. QA & CAPA: Set quality goals, analyze defects, and drive corrective actions. ii. Risk Control: Evaluate production issues and adverse events for immediate mitigation. iii. QMP: Execute Quality Management Plans and report results.
Three-Year Non-Compliance Record: None.
