services

Services

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Source Approvals

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.

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Device Approvals

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.

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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.

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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 leakage and 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.

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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.

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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.

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Training

We offer Classroom Training in the form of Radiation Safety Officer Training and Custom, Onsite training.

We also offer Online Training.

Click here for more details

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Leak Test Kit

Updated pricing 1/16/2013

Leak test kits are available for purchase at the following rates:

1 = $25 each

6-10= $22 each,

> 10 request a quote info@irsc-inc.com

The turn around time is within 48 hours. Same day analysis is available at an additional charge. A leak test certificate will be provided for each test. A reminder postcard or e-mail will be sent one month before the next test is due.

You may order online as a New Customer or Returning Customer, or print and fax an order form to 781.207.0453.

Secured Checkout – All transactions are secure with Comodo SSL encryption technology

Analysis is provided by M. S. Galanek, Massachusetts Radiation Control Program License No. 13-3021. For mailing in samples, please send them to:

Mitchell Galanek
77 Massachusetts Avenue
Room N52-496
Cambridge, MA 02139

For Drop off:

M.S. Galanek
265 Mass Ave.
Bldg N52, 4th Floor
Cambridge, MA 02139

Leak Test Instruction

Order Leak Test Kit

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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.

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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.