Quality and Compliance

Production and Quality Systems

Quality is imbued in our DNA and we embrace the Japanese philosophy of continuous improvement.

We are dedicated to applying a quality mindset and processes to everything we do:
from precise production protocols, stringent testing of products, careful sales assessment and attentive customer service, to the most efficient delivery procedures in order to make our clients get exactly what they need, when they need it.

Quality processes, quality products, quality results.

Kitazato’s factory was established in Fuji (Shizuoka) in 2005 and moved in 2020 to a large facility in the same city, incorporating the most advanced technology for guaranteeing quality in each of the production, storage and distribution phases of our products.

Our products are stored in optimal conditions  for their future use, maintaining the cold temperature throughout the delivery process when required, thanks to our efficient packaging procedures.

The Quality Management System implemented at Kitazato acts in compliance with legal and regulatory provisions and works to continuously improve. Thanks to this, Kitazato has the required control procedures to market the best products, of the best quality, with the sole objective of obtaining the best results for our customers, gaining and maintaining their trust.

Regulatory Compliance

Kitazato in Japan, as well as our authorized representative Dibimed in Europe and the United States, undergo periodic reviews of our Total Quality Management systems and implement updates and on-going improvements to these systems. This results in obtaining of the ISO 13485 certification, specific to medical device manufacturers, that confirms that our processes go above and beyond the necessary requirements for adequate and safe operations.

In addition to our confirmed Total Quality Management System, Kitazato also processes the appropriate registrations with notified bodies to certify that our systems and procedures comply with legal requirements for sale and distribution of our products. Specifically, a majority of Kitazato’s products are FDA approved. Kitazato also holds valid CE certificate for its products marketed in the European Union under MDD requirements and currently undergoing assessment under MDR requirements by BSI (2797) Notified Body.

Information Security Policy

At Kitazato, we strongly value the trust of our clients and the privacy of both customer and patient information.
To protect this information from any threat of unauthorized access, crime, disaster or any possible error, our team heavily invests resources to constantly update and protect our security system.

Action Guidelines

Information Security Management System

Information’s security is of high importance to us. Our system ensures the confidentiality and completeness of all the information treated.

Regulatory Compliance

We act in compliance with the Private Information Protection Law and related laws, regulations and guidelines regarding information security requirements.

Staff Training

All employees at Kitazato are educated and trained in order to fully understand the high importance of information security and to act in compliance with its respective regulation.

Continuous Improvement

We are constantly working to improve our information security system by evaluating our information control system and re-examining our Information Security Policy and regulations on regular basis.