Compliance is a document trail, not a badge on a website
Anyone can put a certification logo in a footer. What matters when a surveyor arrives is whether the paperwork behind the equipment exists, is dated, and names the person who signed it. This page sets out our regulatory position and exactly what documentation you receive.
Supplied with every project
- Manufacturer declaration of conformity
- Installation qualification record
- Electrical safety test results
- Calibration certificate with traceability
- Acceptance test protocol, signed
- Training attendance register
- Warranty registration confirmation
- Planned maintenance schedule
Registrations and standards
We distinguish between what we hold, what we align to, and what our manufacturers hold. Conflating the three is how compliance claims become misleading.
FDA device establishment registration
Registered as a device establishment with the US Food and Drug Administration, with device listings maintained for the categories we distribute, refurbish and service.
State medical device distribution licensing
Licensed to distribute medical devices in California, with out-of-state registrations maintained where the destination state requires them.
General and professional liability cover
Commercial general liability, products liability and professional indemnity cover; certificates of insurance issued to your risk team on request.
ISO 13485 quality management principles
Refurbishment, calibration, complaint handling, corrective action and traceability run against documented procedures modelled on ISO 13485.
NFPA 99 and AAMI electrical safety practice
Electrical safety testing performed to recognised healthcare facility standards, with results recorded against each asset tag.
Joint Commission EC and DNV expectations
Service records structured around the equipment management standards accreditation surveyors actually cite.
FDA 510(k) clearance or PMA approval
Every device we supply is cleared or approved for its intended use in the United States. Clearance numbers are supplied on request before purchase.
CE marking, where applicable
For imported systems, the manufacturer holds the CE technical file and declaration of conformity, which we pass through to you.
UL / ETL electrical listing
Devices carry the relevant nationally recognised testing laboratory listing for the environment they are installed in.
Registration numbers, licence copies, certificates of insurance and W-9 documentation are issued directly to your procurement or compliance team on request. We do not publish them here because the numbers change and a stale page helps nobody.
HIPAA and equipment that holds PHI
Modern imaging and monitoring equipment stores protected health information. A service engineer with a laptop plugged into a modality is a HIPAA exposure whether or not anyone acknowledges it. We treat it as one.
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Business associate agreements
We sign a BAA before any engagement where our engineers may encounter PHI, and we will work from your paper rather than insisting on ours.
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Documented media sanitization
Devices removed from service are sanitized to NIST 800-88 guidance, with a certificate of sanitization issued per asset.
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Access discipline on site
Engineers work to least-privilege access, never export patient data to portable media, and log every system they connect to.
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Incident reporting
Any suspected exposure is reported to your privacy officer within 24 hours, in writing, with the facts we have at that point.
Recalls, safety notices and reporting
Distributors carry statutory reporting duties that do not end at the point of sale. Ours run for the life of the device in your facility.
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Recall and field-action notification
We hold serial numbers against your asset list. When a manufacturer issues a field safety notice, we contact affected customers directly rather than waiting for you to find it.
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Medical Device Reporting
Adverse events involving devices we supplied are reported to the manufacturer and, where required, to the FDA within statutory timeframes.
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Unique Device Identification
UDI data is captured at intake and supplied in your handover file so your CMMS records match the regulatory record.
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End-of-support tracking
We flag manufacturer end-of-support dates on your asset list ahead of time, so replacement lands in a budget cycle rather than an emergency.
What "refurbished" means when we say it
The word is used to describe everything from a full rebuild to a wipe-down and a new sticker. Ours is a written eight-stage process, and you receive the record for your specific serial number.
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01
Intake & provenance
Serial number, ownership history, service history and hour meter recorded. Devices with unverifiable provenance are rejected.
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02
Data sanitization
Any storage holding patient data is sanitized and certified before the unit enters the workshop.
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03
Full teardown
Wear components, seals, batteries, filters and consumable assemblies replaced regardless of measured condition.
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04
Component testing
Subassemblies tested against manufacturer tolerance. Out-of-spec parts replaced with OEM or OEM-equivalent stock.
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05
Software & firmware
Brought to the manufacturer-supported release, with licensing verified as transferable.
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06
Calibration
Calibrated against instruments with traceability to national standards; certificate issued with measured values.
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07
Electrical safety
Leakage current, earth bond and dielectric testing performed and recorded to recognised healthcare standards.
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08
Burn-in & sign-off
Extended operational run under load, then a named technician signs the release record that ships with the unit.
Need our documentation for a vendor review?
Send us your vendor credentialing checklist and we will return it completed, with the supporting certificates attached, rather than asking you to chase individual documents.