Seabrook Medical is certified to be in compliance with the quality standard of EN ISO 13485 .

Our quality systems are also structured to meet the requirements of FDA's Quality System Regulation, 21 CFR Part 820, FDA Registration Number: 1221763.

As a contract manufacturer of medical devices for the orthopaedic market we understand the critical nature of the products we make and the importance of their performance to both our customers and ultimately their patients.

It is therefore our practice to continuously improve our quality management systems to meet the needs of our customers and provide products and services of the highest possible quality.

Japanese FMA