Industries
Radiological Health & Radiation-Emitting Products
Electronic products that emit radiation carry performance standard, recordkeeping and reporting obligations alongside any device quality system requirements. Manufacturers frequently have one of the two systems in place and not the other.
xFDA supports manufacturers of radiation-emitting electronic products with quality systems that cover both device and radiological health obligations, manufacturing and production controls, testing and certification recordkeeping, reporting practices, audits and remediation.
How we support this sector
Where engagements typically focus
- Quality systems covering both device and radiological health obligations
- Manufacturing and production controls for electronic product assembly
- Testing, certification and performance recordkeeping practices
- Reporting and recordkeeping obligations for radiation-emitting products
- Supplier controls for critical electronic and shielding components
- Internal audits, gap assessment and remediation planning
Scope is confirmed against verified consultant experience before an engagement is accepted.
When companies call us
Situations we are asked into
- A manufacturer has a device quality system but no radiological health recordkeeping program.
- Testing and certification records cannot be tied to specific production units.
- A design change affects radiation output and the change control record does not show it was evaluated.
- Reporting obligations were identified late and need a documented catch-up plan.
- Component suppliers for shielding or interlocks have never been formally controlled.
Questions we are asked
Radiological Health & Radiation-Emitting Products: common questions
Direct answers from the consultants who do this work.
- Which products are treated as radiation-emitting electronic products?
- Electronic products that emit ionizing or non-ionizing radiation as part of their operation or as a by-product — including many medical imaging, therapeutic, laser and industrial systems. Medical products can carry both device quality system and radiological health obligations at the same time.
- How do radiological health obligations differ from device quality system requirements?
- Device requirements govern how the product is designed and produced. Radiological health obligations add product-specific performance, testing, certification, recordkeeping and reporting expectations that a standard quality manual usually does not address.
- What records should support certification?
- Test methods and acceptance criteria, calibrated test equipment records, unit-level or lot-level test results traceable to production records, and documented review before the product is certified and shipped.
- What happens when a design change affects radiation output?
- The change must be evaluated under change control with retesting where warranted, records updated, and any applicable reporting obligation assessed. The common failure is treating it purely as an engineering change.
- Do you take engagements outside verified consultant experience?
- No. Scope in this sector is confirmed against a specific consultant's verified experience before an engagement is accepted.
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