About Us
1
Partnership Proposals: Contact Us
2
Security of Testing Data
3
Certification goals to be achieved in progressive stages4
https://www.airqisupply.com.tw/en/custom_141182.html Certification goals to be achieved in progressive stages Certification goals to be achieved in progressive stages 【Professional Leadership · Pure Commitment】Our Quality Commitment to Global Class II Medical Device Standards In an era where health technology evolves daily, we remain steadfast in holding ourselves to the most rigorous standards. To provide health solutions with professional assurance, we are comprehensively upgrading our facilities to meet Class II Medical Device certification and regulatory requirements, elevating product safety from the R&D stage to the pinnacle of international compliance.   To us, quality is the fundamental respect we hold for life. To achieve the status of a Class II medical device manufacturer, we have set the following certification goals, which will be completed in progressive stages:  I.   Core Quality Systems: Building an International Production Defense Every product we create originates from a precise and controlled Quality Management System (QMS), ensuring scientific rigor from the laboratory to the end-user: ISO 13485:2016 (Medical Devices — Quality Management Systems): We implement specialized international standards to establish full-lifecycle quality tracking across design, development, production, and after-sales service. National QMS Certification: Fully compliant with Taiwan’s Medical Device Management Act, ensuring our manufacturing environment maintains medical-grade stability and consistency.  II.   Global Market Access: Cross-Border Professional Recognition To bring our innovative technologies to users worldwide, we are actively pursuing market authorization and registration, aligning with the world's most stringent medical regulatory frameworks: TFDA Medical Device License (Taiwan): Rooted locally, obtaining official authoritative safety certification. EU CE (MDR) & U.S. FDA: Embracing top-tier global medical standards to demonstrate our products' competitiveness under international regulations. JIS/PMDA (Japan): Meeting the Japanese market’s demand for extreme precision and high-quality standards.   III. Scientific Evidence & Third-Party Testing: Let the Data Speak We reject ambiguity and rely solely on empirical evidence. We maintain a long-term partnership with SGS, the world’s leading inspection and testing organization, to conduct multi-dimensional third-party scientific testing. Through impartial and transparent reports, we provide substantial safety evidence for every user.  IV.   Medical Tech Meets Purity: Practicing the Clean Label Philosophy Beyond technical breakthroughs, we focus on long-term human-friendliness. We combine medical-grade rigor with the pursuit of natural purity: TOC (Twin Oaks Certified) Organic Certification: We screen for natural and eco-friendly premium materials from the source. Clean Label Standards: In response to the growing "Clean Label" movement in Europe and America, we are committed to minimizing unnecessary chemical burdens, seeking the perfect balance between minimal ingredients and maximal functional efficacy. Our Mission: Your Most Solid Shield for Health From R&D to multinational certifications, and from scientific data to purity labels, every step we take is dedicated to transforming professional technology into the most thoughtful protection for your well-being.
https://www.airqisupply.com.tw/en/ AIRQISUPPLY
Partnership Proposals: Contact Us
About Us Partnership Proposals: Contact Us Security of Testing Data Certification goals to be achieved in progressive stages

【Professional Leadership · Pure Commitment】Our Quality Commitment to Global Class II Medical Device Standards

In an era where health technology evolves daily, we remain steadfast in holding ourselves to the most rigorous standards. To provide health solutions with professional assurance, we are comprehensively upgrading our facilities to meet Class II Medical Device certification and regulatory requirements, elevating product safety from the R&D stage to the pinnacle of international compliance.

 

To us, quality is the fundamental respect we hold for life. To achieve the status of a Class II medical device manufacturer, we have set the following certification goals, which will be completed in progressive stages:

 I.   Core Quality Systems: Building an International Production Defense

Every product we create originates from a precise and controlled Quality Management System (QMS), ensuring scientific rigor from the laboratory to the end-user:

  • ISO 13485:2016 (Medical Devices — Quality Management Systems): We implement specialized international standards to establish full-lifecycle quality tracking across design, development, production, and after-sales service.
  • National QMS Certification: Fully compliant with Taiwan’s Medical Device Management Act, ensuring our manufacturing environment maintains medical-grade stability and consistency.

 II.   Global Market Access: Cross-Border Professional Recognition

To bring our innovative technologies to users worldwide, we are actively pursuing market authorization and registration, aligning with the world's most stringent medical regulatory frameworks:

  • TFDA Medical Device License (Taiwan): Rooted locally, obtaining official authoritative safety certification.
  • EU CE (MDR) & U.S. FDA: Embracing top-tier global medical standards to demonstrate our products' competitiveness under international regulations.
  • JIS/PMDA (Japan): Meeting the Japanese market’s demand for extreme precision and high-quality standards.

 

III. Scientific Evidence & Third-Party Testing: Let the Data Speak

We reject ambiguity and rely solely on empirical evidence. We maintain a long-term partnership with SGS, the world’s leading inspection and testing organization, to conduct multi-dimensional third-party scientific testing. Through impartial and transparent reports, we provide substantial safety evidence for every user.

 IV.   Medical Tech Meets Purity: Practicing the Clean Label Philosophy

Beyond technical breakthroughs, we focus on long-term human-friendliness. We combine medical-grade rigor with the pursuit of natural purity:

  • TOC (Twin Oaks Certified) Organic Certification: We screen for natural and eco-friendly premium materials from the source.
  • Clean Label Standards: In response to the growing "Clean Label" movement in Europe and America, we are committed to minimizing unnecessary chemical burdens, seeking the perfect balance between minimal ingredients and maximal functional efficacy.


Our Mission: Your Most Solid Shield for Health

From R&D to multinational certifications, and from scientific data to purity labels, every step we take is dedicated to transforming professional technology into the most thoughtful protection for your well-being.

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