Quality Policy | Excellence in Medical Device Compliance & Quality | Manual Resuscitator BVMs for Critical Care Settings | Asia Connection

Asia Connection Co., Ltd. - Quality Policy | Asia Connection Co., Ltd. supplies emergency medical and homecare products with FDA registration, ISO 9001, ISO 13485 and CE certificates under MDR (Regulation (EU) 2017/745), along with design, OEM, and manufacturing capabilities.

Asia Connection Co., Ltd. - Quality Policy

Quality Policy

Quality Policy | Excellence in Medical Device Compliance & Quality

At Asia Connection, our quality policy is built on a foundation of unyielding standards and continuous evolution. As a leading medical device supplier, we are dedicated to providing products that not only meet but exceed the safety and regulatory expectations of our global stakeholders.


Our Core Quality Pillars
    To maintain our reputation for excellence, we adhere to four fundamental principles:
  • Full Dedication
  • Every team member is committed to the highest standards of integrity and precision in every medical product we deliver.

  • Continuous Improvement
  • We constantly refine our processes and Quality Management System (QMS) to stay at the forefront of the healthcare industry.

  • Customer Satisfaction
  • We focus on understanding and anticipating the needs of healthcare providers and patients worldwide.

  • Sustainable Development
  • We ensure our operations and growth strategies support long-term environmental and business sustainability.
Global Regulatory Compliance & Standards
    Asia Connection operates under a world-class regulatory framework. We strictly follow international standards to ensure market access and patient safety for our clients:
  • ISO 13485 / ISO 9001
  • Certified quality management systems for medical device design and manufacturing.

  • FDA Compliance (21 CFR 820)
  • Adherence to Quality System Regulations (QSR) for the U.S. market.

  • Post-Market Surveillance (21 CFR 803 & 806)
  • Strict monitoring and reporting protocols for medical device safety and corrections/removals.

  • PRisk Mitigation
  • We empower every employee to identify and resolve potential issues, ensuring proactive risk reduction in response to internal and external changes.
Innovation Through Integration
    We don't just supply products; we integrate expertise. By leveraging our diverse knowledge in design and manufacturing, we effectively harmonize the capabilities of multiple suppliers to offer:
  • Advanced R&D
  • Upgrading design abilities to bring innovative medical products to market.

  • Supply Chain Integrity
  • Rigorous vetting of new suppliers and products to maintain a consistent quality baseline.

  • Collaborative Teamwork
  • Utilizing collective skills to enhance customer satisfaction and maintain a sustainable global operation.
Frequently Asked Questions
  • What quality standards does Asia Connection follow?
  • Asia Connection is compliant with ISO 13485, ISO 9001, and U.S. FDA 21 CFR 820 standards. We ensure all medical devices meet rigorous international regulatory requirements for safety and efficacy.

  • How does Asia Connection manage medical device risks?
  • We implement a proactive risk management mechanism where all employees are authorized to identify and solve quality issues. This ensures we adapt quickly to market changes and maintain the highest safety standards for stakeholders.

  • Does Asia Connection provide FDA-compliant medical products?
  • Yes. Our manufacturing and quality systems align with 21 CFR 820, 803, and 806, ensuring that our products and processes meet the strict reporting and quality standards required for the United States and global markets.

Quality Policy | CPR Masks Designed for Emergency and First Response Manufacturer | Asia Connection

Located in Taiwan since 1993 (Parent Company 1977), Asia Connection Co., Ltd. is a medical and homecare products supplier. Their main products, including Nasal Aspirator, Breast Pump, CPR Mask, Pocket Resuscitator, Nasal Cannula, Oral Airway, Mesh Nebulizer, Head Immobilizer, Air Cushion Anesthesia Mask, Stethoscope, etc.

Asia Connection specializes in medical and homecare products that are indispensable in ambulances, emergency rooms, and other critical care settings. Ensure optimal patient outcomes with our high-quality products. Whether you prefer disposable PVC or reusable Silicone, Asia Connection provides a range of Manual Resuscitator BVMs to meet the diverse needs of hospitals and wholesale buyers.

Asia Connection has been offering customers high-quality medical and homecare products such as resuscitator BVM and nasal aspirator since 1993 (Parent Company 1977), both with advanced technology and 49 years of experience, Asia Connection ensures each customer's demands are met.