Quality Standards & Licenses

As a supporting service to the highly discerning medical device industry, the importance of quality systems and standards in place cannot be understated.

Grand Ten has been certified for applicable international quality standards and continues to meet the stringent safety and security regulations governing the use of radioactive materials while also meeting the high technical and quality standards demanded by our customers today.

EN ISO 13485<small> </small>:<small> </small> 2016​ + A11 : 2021
EN ISO 13485 : 2016​ + A11 : 2021Provision of Gamma Irradiation Services involving the Process of Sterilization of Medical Devices in accordance with EN ISO 11137-1:2016+A11:2021
EN ISO 11137-1<small> </small>:<small> </small>2015​ + A2 : 2019
EN ISO 11137-1 : 2015​ + A2 : 2019Sterilization of health care products: Radiation - Part 1. Requirements for dev't, validation & routine control of sterilization process for medical devices
21 CFR Part 820 - Quality System Regulation (QSR)
21 CFR Part 820 - Quality System Regulation (QSR)U.S. Food and Drug Administration (FDA)
Japanese Good Manufacturing Practice (GMP)
Japanese Good Manufacturing Practice (GMP)Ministry of Health, Labor and Welfare
Atomic Energy Licensing Board
Atomic Energy Licensing Board (AELB) – MalaysiaClass A, D, E Operating License – LPTA/A/1835. Licensed to purchase, own, possess, use, transfer, handle, or store radioactive material in accordance to the Atomic Energy Licensing Act (1984) - Radiation Protection Licensing Regulations (1986)
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