Quality & ESG

Certifications, testing, and sustainable material strategies for long-term trust.

QUALITY & SUSTAINABILITY

Quality Is Our Promise

From quality management and testing to sustainable supply chains, HWAYING TECH incorporates international standards into its manufacturing processes to create a reliable, safe, and quality-driven production system that meets medical device industry requirements.

QUALITY MANAGEMENT

Quality from Development
to Production

HWAYING TECH maintains close communication with customers and actively monitors post-market feedback to continuously improve products and manufacturing processes through systematic quality management.

Guided by our quality policy—“High Quality, Value Creation, and Dedicated Service”—we address quality and customer needs throughout product development, production, and after-sales support, fostering long-term partnerships built on trust.

By integrating international regulations and quality standards into our management systems, we help customers reduce development and manufacturing risks.

CONTINUOUS IMPROVEMENT

PLAN

Set quality objectives and define process requirements

Apply standardized procedures and management practices

CHECK

Perform testing, verification, and traceability

ACT

Continuously improve quality and operational efficiency

CERTIFICATIONS

Certifications

HWAYING TECH maintains a quality management framework designed to meet the needs of the medical device industry, supporting product development, manufacturing, and regulatory requirements across international markets.

ISO

ISO 13485:2016

A medical device quality management system supporting product development, manufacturing, and quality control.

TFDA

Taiwan FDA Certification

Relevant certifications provide a foundation for product quality and medical device manufacturing capabilities.

GLOBAL

International Regulatory Support

Building on our established quality management system, we help customers navigate regulatory requirements, including U.S. FDA regulations and the EU Medical Device Regulation (MDR).

TESTING & VALIDATION

Making Quality Measurable and Verifiable

HWAYING TECH provides in-house testing and measurement capabilities to streamline product development and verification, helping customers shorten development cycles.

PRECISION MEASUREMENT

Our measuring equipment is calibrated by ISO/IEC 17025-accredited laboratories to ensure accurate, traceable results.

CUSTOMIZED TESTING

We develop dedicated inspection equipment and test methods tailored to product characteristics.

PACKAGING TESTING

We provide comprehensive packaging evaluations in accordance with applicable international standards.

VALIDATION STANDARDS

Validation Scopes & Applicable Standards

Validation Scopes	Applicable Standards
Sterile Barrier Systems	ISO 11607, EN 868-5
Ethylene Oxide (EO) Sterilization	ISO 11135, ISO 10993-7
Biocompatibility	ISO 10993 Series
Aging Tests	ASTM F1980
Process Validation	GHTF SG3/N99

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ESG & SUSTAINABILITY

A More Sustainable Future
Through Manufacturing

From local sourcing and material innovation to community engagement, HWAYING TECH integrates sustainability into its operations to reduce environmental impact and create positive social value while maintaining quality and efficiency.

Taiwanese Raw Materials and Local Supply Chain

01 / LOCAL SUPPLY CHAIN

Local Sourcing for a Sustainable Medical Supply Chain

HWAYING TECH prioritizes Taiwanese materials and builds long-term supplier partnerships to ensure material quality, efficient sourcing, and supply continuity.

Reduced Transportation Distance

Minimizing logistics costs and environmental impact by shortening transportation routes.

Enhanced Supply Chain Resilience

Reducing exposure to disruptions from international logistics, tariffs, and market fluctuations.

Responsive Supply Support

Flexibly supporting product development, pilot runs, and mass production.

LOCAL MATERIAL PARTNERS

We primarily source materials from established Taiwanese suppliers, including Formosa Plastics, Formosa Chemicals & Fibre, Nan Ya Plastics, Chi Mei, Grand Pacific Petrochemical, Chang Chun Group, LCY Chemical, and USI Corporation.

02 / SUSTAINABLE MATERIALS

Exploring Eco-Friendly Materials

In response to global sustainability trends, HWAYING TECH evaluates the environmental impact of medical products throughout their life cycles and explores eco-friendly materials and process improvements.

NOW

MATERIAL EVALUATION

Assessing material options suitable for medical device applications.

DEVELOPMENT

VALIDATION & DEVELOPMENT

Validating materials, testing reliability, and optimizing processes to meet safety, performance, and manufacturing needs.

FUTURE

SUSTAINABLE MATERIALS

Exploring eco-friendly alternatives to reduce environmental impact throughout the product life cycle.

03 / SOCIAL RESPONSIBILITY

Creating Positive Social Impact

From charitable giving and community care to civic engagement and educational exchange, HWAYING TECH contributes its resources and expertise to fulfill its corporate responsibilities.

Charitable Initiatives and Community Support Activities

COMMUNITY CARE

Charitable Initiatives & Community Support

HWAYING TECH supports community welfare through its involvement with the Taoyuan City Merry House Social Welfare Foundation and participation in the “2022 Merry Life: Art for Charity” fundraising fair.

SOCIAL PARTICIPATION

Civic Affairs & Educational Exchange

We encourage our management team to engage in public affairs, volunteer service, and educational exchange, fostering meaningful connections among businesses, schools, and communities.

QUALITY, INNOVATION & SUSTAINABILITY

HWAYING TECH will continue to strengthen local sourcing, material development, and community engagement while upholding medical product quality and safety. We strive to advance a more efficient, resilient, and sustainable medical device supply chain.

QUALITY YOU CAN TRUST

Your Trusted Manufacturing Partner,
from Quality to Sustainability

From product development and validation to mass production, HWAYING TECH combines comprehensive quality management with manufacturing expertise to help customers bring reliable medical devices to market.