- ISO 13485 certification
- Company-wide quality program
- US FDA 21 CFR Part 820 (QSR) compliance
- Device History Records (DHR)
- Device Master Records (DMR)
Delta Asia commits to provide the highest quality products that meets both our customers' expectations and relevant regulations and international standards for medical devices. To Delta Asia, quality means more than the fulfillment of specified requirements. We build quality into every step of our manufacturing process development, from the start of planning through to mass production.
To achieve this, Delta Asia has implemented a quality system that complies with US FDA 21 CFR Part 820 and ISO 13485. The quality system and practices are audited not only internally but also regularly by leading pharmaceutical and biotech customers. Furthermore, Delta Asia implements Corrective and Preventive Action (CAPA) quality process to ensure the quality of our products is continuously improved.
Supplier evaluations are conducted according to quality system procedures. We also adequately test materials against the international requirements for material safety. Device History Records (DHR) are reviewed prior to product release to ensure the product manufactured meets the requirement of good manufacturing practice (GMP).
Delta Asia creates a culture of continuous improvement to achieve the goal of highest customer satisfaction. Our company-wide quality program relies on the involvement of each employee within every department. We encourage a strong feeling of commitment to providing quality products, resulting in a sense of pride and accomplishment throughout the organization.