① Quality Management · Commitment to Establishing Quality Management Systems and Continuously Improving

King Service strictly adheres to the quality management requirements of USQSR820, ISO13485, and ISO11135 to establish a robust quality management system. From sterilization validation to routine sterilization and testing processes, stringent quality control measures are implemented.

② Sterilization Services · Emphasis on DQ (Design Qualification) Prior to PQ (Performance Qualification), Deep Collaboration with Clients, and Rigorous Project Management with Extensive Experience

1. So far, King Service team has conducted hundreds of sterilization validation services for clients. Our validation protocols and reports comply with the registration requirements of the US FDA, CE, and NMPA, providing strong support for the successful market entry of clients' products. There have been no instances where validation protocols, reports, or test results delayed product launches, nor any product recalls due to sterilization efficacy issues.

2.King Service team has extensive experience in sterilization validation for interventional and implantable medical devices. During the product design phase, we provide recommendations on packaging and sterilization, assisting clients in optimizing product structure and materials to reduce sterilization costs. We have established long-term, stable partnerships with many clients.

③Advanced Equipment · Production Capacity and Lead Time

1. King Service's sterilization facility boasts ample production capacity, with a monthly sterilization volume of up to 8,000–10,000 cubic meters.

2.Our sterilization facility operates on a 5-day × 24-hour work schedule, meeting urgent delivery and sterilization needs. During peak seasons, we switch to a 7-day × 24-hour shift.
3.King Service is equipped with backup generators, ensuring seamless transition within 10 minutes in case of power outages, with no disruption to sterilization processes.

④ Professional Team · Handling of Exceptions and Emergency Situations

We proactively address corrective actions identified during client audits, take a responsible approach to resolving operational challenges collaboratively, and continuously improve our processes.