Expert Radiation Safety Support That Helps You Comply, Operate Confidently, and Grow

At International Radiation Safety Consulting Inc. (IRSC Inc.), we specialize in providing strategic radiation safety and regulatory services for manufacturers, distributors, and end users of instruments and equipment containing radioactive sources or radiation-emitting systems. Our services help you meet local, state, federal, and international regulatory requirements with clarity and confidence.

Whether you’re launching a new product, expanding into new markets, managing compliance, or strengthening your internal safety programs, we’re here to guide you every step of the way.
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Our Service

Our Services At A Glance

Source Approvals & Regulatory Strategy

We help you prepare and submit complete source approval applications, anticipate regulator questions, and shorten review timelines. Our team guides you through every step so you can launch products with confidence.

Radioactive Device Registrations

If your device contains a sealed source, we manage the entire registration process for you. From documentation to agency follow-ups, we make sure your product meets state and federal device approval requirements.

U.S. & International Regulatory Support

Selling into multiple states or countries? We research the rules, map out requirements, and help you stay compliant everywhere you operate. Clear guidance, no guesswork, fewer delays.

Licensing Assistance & Amendments

Whether you’re applying for a new license or modifying an existing one, we handle preparation, submission, and communication with regulators. You get the right license for your activities without the stress.

Quality Assurance & Quality Control Consulting

We help build practical QA/QC programs that align with regulatory expectations and real production workflows. Manuals, procedures, and controls are designed to support safe, compliant manufacturing.

Radiation Safety Reviews & Audits

We evaluate your radiation safety program, identify compliance gaps, and recommend fixes before regulators find them. Perfect for routine assessments, inspections, or peace of mind.

Shielding Design Plans

Our experts design shielding plans for X-ray, analytical systems, accelerators, and more. We also help file plans with regulators and provide documentation needed for approval and installation.

FDA Product Reporting Assistance

If your device falls under FDA radiation-emitting product rules, we prepare and submit the required reports. You get compliant documentation and smoother approval pathways for commercial distribution.

Our Core Services

01

Source Approvals & Regulatory Strategy

Getting regulatory approval for radioactive sources and related systems can be complex and time-consuming. We help you navigate that process from start to finish—helping prepare complete applications, anticipate agency feedback, and reduce review delays.

This service ensures your products and sources meet requirements from the U.S. Nuclear Regulatory Commission (NRC), Agreement States, or international regulatory agencies.

✔  Includes compliance guidance with ANSI and ISO standards (where applicable)
✔  Helps avoid costly resubmissions and regulatory pushback
✔  Tailored strategies for your product type and market
  • Ideal For
Manufacturers and distributors launching new radioactive sources, gauges, detectors, or radiation-emitting systems.
02

 Radioactive Device Registration

If your device contains a sealed radioactive source, it likely must be registered or approved before distribution or commercial use. We prepare and manage your device registration applications so you can get authorized without unnecessary hurdles.

This service covers multiple regulatory frameworks—including NRC and Agreement State requirements..

✔  Assistance with documentation and classification
✔  Guidance based on established industry standards like NUREG 1556, ISO 2919, and HPSN43.8
✔  Industry-aligned submission strategies
  • Ideal For
Companies producing industrial gauges, detectors, and other sealed-sourcedevices.
03

Comprehensive U.S. & International Regulatory Support

Regulations change depending on the jurisdiction, and requirements can vary widely between states or countries. We provide thorough research and ongoing support for any regulatory landscape—including multi-jurisdiction compliance planning, licensing, and approvals.

With experience across more than 70 countries, we help you interpret regulatory frameworks and implement solutions that keep you compliant at every level.

✔  Regulatory requirement research and summaries
✔  Country-specific guidance and language support
✔  End-to-end submission and follow-up support
  • Ideal For
Companies selling or planning to sell products internationally
04

Licensing Assistant & Amendments

Radiation licenses and registrations are not one-size-fits-all. Our experts help determine which license or authorization best fits your business—whether it’s possession, use, distribution, or something more specialized.

We manage the entire process for new licenses, amendments, renewals, or updates.

✔  Interpretation of licensing types and requirements
✔  Application preparation and submission
✔  Coordination with regulatory agencies
  • Ideal For
Organizations needing licensing support or modifications to existingauthorizations.
05

Quality Assurance & Quality Control Consulting

Transitioning from prototype to production can create compliance challenges. Our QA/QC support services help you:

✔  Develop quality manuals
✔  Create practical process controls
✔  Implement procedures that support regulatory compliance

This service bridges the gap between product design, manufacturing, and regulatory expectations.
  • Ideal For
R&D teams, manufacturers scaling up production, and quality managers.
06

Radiation Safety Reviews & Audits

Is your radiation safety program actually compliant? Our radiation safety reviews and audits assess your facilities, documentation, and procedures to identify gaps before regulators do.

We conduct audits for:

• Devices with radioactive material
• X-ray systems and accelerators
• Laser safety
• Program documentation and procedures
  • Ideal For
Organizations preparing for inspections or seeking continuous improvement.
07

Shielding Design Plans

Radiation shielding isn’t guesswork—it’s science. Our team designs shielding plans for any ionizing radiation source or equipment, including industrial X-ray, analytical systems, accelerators, and irradiators. We also help file plans with regulatory agencies and follow up until compliance is confirmed.
  • Ideal For
Facilities installing or modifying equipment with radiation exposure potential.
08

FDA Product Reporting Assistance

Many devices that emit radiation must comply with FDA requirements, especially if distributed commercially. We assist with filing the required reports with the U.S. Food and Drug Administration (CDRH) to ensure your products meet both safety and regulatory expectations.
  • Ideal For
Manufacturers of X-ray and laser products subject to FDA reporting.

Why Work With IRSC?

We combine deep regulatory knowledge with practical experience in industrial environments. Our team has supported organizations of all sizes, from startups to global enterprises, in achieving compliant and successful operations.

You benefit from:

✔  Expert guidance from professionals withregulatory and industry experience
✔  Clear explanations that simplify complex requirements
✔  A partner who handles the heavy lifting so you stay focused on your business
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