We assist in the design and approval of radioactive sources according to existing standards.
By guiding you through the regulatory approval process, we will help you to obtain approval from the U.S. NRC, Agreement States, or the Regulatory Agencies of other countries.
We provide guidance on compliance with ANSI and ISO Standards.
It is vital to have a complete application and a strategy before submission.
Radioactive Device Registration
We assist in the design and approval of devices containing sealed sources. We will guide you through the regulatory approval process in order to obtain approval from the U.S. NRC, Agreement States, or the Regulatory Agencies of other countries, Agreement States, or the Regulatory Agencies of other countries. We provide guidance on compliance with ANSI and ISO Standards.
Our approval is based on the requirements and classification of following documents:
US NRC NUREG 1556, Volume 3
Comprehensive U.S. & International Regulatory Support
At IRSC we provide radiation safety consulting and various radiation safety services to all types of businesses. We will conduct research on requirements for state/province, nationwide, and international on topics which may have different regulatory requirements in different areas of jurisdiction.
The regulatory climates of other countries are complex and are constantly changing. Therefore, it can be quite time assuming to understand their radiation safety regulatory requirements, and even more so if there is a language barrier. We used translators as necessary to read the regulations, and then we call the regulatory with an interpreter to confirm what the requirements are.
Let us know your country of interest and our radiation safety consultants will provide you with a comprehensive report about the regulatory requirements.
If you choose to obtain an approval in the country of interest, we will assist you completing the required license, registration, or permit application and we will then take you through the approval process from start to finish, giving you authorization to commercially distribute your products in that country.
Having dealt with the regulators and regulatory requirements in over 70 countries to date, our radiation safety consultants have the experience and expertise to ensure a successful device approval no matter where you are selling your product.
If you don’t see your country of interest, we will use the same process to obtain the regulatory requirements for you.
Licensing and Amendments
Need help with obtaining a radioactive materials license? We will assist you with the process from start to finish. Our staff will consultants with help you to determine which type of licensing approval you require, such as a possession license, research and development license, or distribution license. We will also obtain your sealed source/device registration (SSDR), also know as “type approval”.
Next, based on what type of product you will be distributing and what it will be used for, we will determine how the end user will be licensed based the following three categories.
Specifically Licensed: The user must possess written authorization in the form of a license to possess and use the device. This authorization includes limitations on the use of the device and requirements for user training in radiation safety. An example of this type of device is a moisture/density gauge used in road construction.
Generally Licensed: The user does not require written authorization in the form of a license to obtain the device, but must adhere to certain regulations regarding periodically testing devices for shutter operation, proper disposal of the device at the end of its service life, and maintaining records. Note that the NRC and Agreement States now require certain generally licensed devices to be registered upon receipt. An example of this type of device is a static elimination device used in the manufacturing industry.
Exempt: There are no regulatory requirements for the end user. An example of this type of device is a smoke detector.
Manufacturing: Quality Assurance & Quality Control
Sometimes it can be difficult for R&D firms to make the transition to manufacturing. We will help ease the process by assisting in writing your Quality Assurance Manual and putting procedures into place to ensure a safe, quality product is produced efficiently.
We will cover all grounds to ensure that you obtain the appropriate radiation license and follow up with the regulators until the process is completed and you obtain the approval you need.
Radiation Safety Reviews and Audits
We will audit your site to ensure compliance with local, state/province, and federal regulations, and industry standards. We have Global Capabilities and can audits sites throughout the world.
Annual program audits increase the compliance level determined from government inspections.
We perform audits for the use of radioactive materials in loose form or contained in products, x-ray or accelerator devices, and laser systems.
Contact our offices for more information about our audit services. We will be more than happy to assist you.
We offer Classroom Training in the form of Radiation Safety Officer Training and Custom, Onsite training.
We also offer Online Training.
Leak Test Kit
IRSC has discountinued providing leak test services as of June 1, 2023.
You may still obtain service by sending orders directly to our contract leak test lab, Atlantic Nuclear by calling them at (800) 878-9118 or emailing them at email@example.com
You can also access from their website here: https://www.atnuke.com/
Thank you for your business.
Shielding Design Plans
IRSC prepares radiation shielding design plans for the use of ionizing radiation for all types of x-ray equipment, including medical and dental x-ray,industrial x-ray systems, open beam analytical x-ray(such as types of XRD), electron beam Irradiators, accelerators, and irradiators.
Our consultants have experience in drafting shielding plans for a variety of use situations. Whatever kind of business you own, we can help you find a solution.
We will draft you a professional report and assist you in filing it with your regulatory agency and following up with them in order for you to receive the required authorization to use your equipment. Once the shielding is installed, we will perform a follow up survey to ensure does rates are below required limits. We will make sure you facility is in compliance when it comes to radiation shielding.
US FDA Product Reports
We also assist with filing US FDA, Center for Devices and Radiological Health Product Reports for x-ray and laser products.