Hakko Medical Device Division

R&D and Quality Management

Aiming to develop original and reliable medical devices

By developing original and reliable minimally invasive medical devices, we contribute to the improvement of patients’ QOL and medical development.

In order to accurately grasp the new needs of medical devices that are required as medical technology advances and to quickly deliver products from the patient’s standpoint, close collaboration with medical sites is essential.

We aim to make progress on a daily basis by closely exchanging information with medical professionals who are at the forefront, and we devote ourselves to creating novel products with unwavering efforts.

Providing products that are trusted in a clean environment and advanced quality system to the medical field

Under the advanced management system, Hakko’s medical devices manufactured in a clean environment backed by ISO13485 * certification are highly evaluated both in Japan and overseas.

*ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard

Pursuing safety and ensuring reliability

Safety required for medical devices! We are making extra effort to ensure the safety of our products.

The GLP test facility, which was established in the hope of delivering safe, secure and effective medical devices to patients as soon as possible, passed conformance test by the Pharmaceuticals and Medical Devices Agency in 2006.

We have an in-house system for biological tests (GLP=Good Laboratory Practice tests) necessary for obtaining manufacturing approval, such as cytotoxicity tests, sensitization tests, intradermal reaction tests, and acute systemic toxicity tests in accordance with ISO10993 *.

We also equipped with FTIR, gas chromatography, atomic absorption analyzers, etc., and make every possible effort to ensure chemical stability of products as well as to confirm the quality of parts materials.

ISO10993: International standard for biological testing of medical devices