Reliability Assurance

Basic Policy

As a provider of products essential to reproductive medicine, Kitazato consider the assurance of the highest levels of quality, safety, and reproducibility across all products and services to be our top priority.

Fully recognizing our responsibility in handling technologies that support the beginning of life, we have established a robust reliability assurance framework based on stringent international standards.

Quality Assurance Philosophy

1. Establishment of a quality assurance system based on international standards
2. Fostering a quality-driven culture in which every employee contributes to quality
3. Ensuring safety and reproducibility based on scientific evidence

Quality Assurance Framework

• Operating a company-wide Quality Management System (QMS) in strict accordance with ISO 13485 standards.
• Rigorous inspection and record management at each stage of the manufacturing process
• Thorough implementation of manufacturing environment monitoring, raw material control, validation, and pre-shipment testing
• Continuous improvement through internal and external audits

Product Safety and Risk Management

In reproductive medicine, even minor differences can affect treatment outcomes; therefore, we conduct rigorous evaluations.

• Biocompatibility testing
• Stability testing
• Component-level quality control testing
• Product-specific risk assessments
• Post-market analysis of safety information

In the event of any nonconformity, we implement immediate root-cause analysis and proactive corrective actions.

Supply Reliability Initiatives

To ensure uninterrupted product availability at clinical sites, we regard stable supply as a core corporate responsibility.

• Securing multiple sourcing routes for raw materials
•  Strengthening our Business Continuity Planning (BCP) through equipment redundancy and strategic inventory management.
• Leveraging our operational expertise gained through serving more than 110 countries worldwide.

Collection of Safety Information and Continuous Improvement

Feedback from medical institutions is actively collected and utilized for product improvement.

• Post-Market Surveillance
• Interviews with healthcare professionals
• Sharing and analyzing clinical data to enhance performance.
• Updating educational materials and Instructions for Use (IFU)

Compliance with International Regulations

• CE marking
• Regulatory submissions to the FDA and other authorities
• Compliance with medical device regulations in various countries and regions (including MDR, TGA, NMPA, etc.)
• Export control and preparation of regulatory documentation