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Quality and compliance
Quality you can show an auditor.
Every unit we supply is traceable to its manufacturer, inspected in an ISO 13485 hub and documented by serial. When a recall lands, we know which of your devices are affected the same day.
All certificates current · audited Feb 2026
ISO 13485:2016
Medical device QMS
FDA
Establishment registration
IEC 62353
Safety testing, every unit
GS1 UDI
Device identification
ISO 9001:2015
Company-wide QMS
SOC 2 Type II
Portal and data controls
Certifications
Certified where it matters.
Certificate
ISO 13485:2016
Quality management system covering storage, inspection, installation and servicing at all three hubs.
Certificate
FDA establishment registration
Registered with the FDA for distribution and servicing activities.
Certificate
IEC 62353 testing
Electrical safety testing on every unit before dispatch and after every repair.
Certificate
GS1 UDI
Unique device identifiers captured at receipt and passed to your asset register.
Certificate
ISO 9001:2015
Company-wide quality management for sales, contracts and customer service.
Certificate
SOC 2 Type II
Customer portal and asset data handled to audited security controls.
Incoming QA
What happens to every device we receive.
01
Receive
Packaging, labels and documents checked against the purchase order.
02
Identify
Serial number and UDI captured; device linked to your order and site.
03
Test
Firmware updated, presets loaded, electrical safety tested to IEC 62353.
04
Release
Signed inspection record attached to the device before it ships.
Recalls and field safety
Recalls handled before they reach the ward.
We monitor manufacturer notices and regulator databases daily and match them to the serials we supplied you.
Same day
Notice matched
Affected serials identified across your sites the day a notice is published.
24 hours
You are told
Your quality and biomed leads receive a list of affected devices and the required action.
Closed out
Documented
Corrective actions are completed, logged and the evidence is filed for your next audit.
Compliance guide
The standards behind every device we supply.
A plain-English guide to the certifications and regulations that apply to medical equipment distribution and service.
ISO 13485:2016
The international standard for quality management systems in the medical device industry. Our certification covers storage, inspection, installation and servicing at all three hubs, and is audited annually by an accredited body.
FDA establishment registration
Distributors and servicers of medical devices in the United States register with the FDA. Registration means our facilities are listed and can be inspected, and that we follow the applicable quality system requirements.
IEC 62353 electrical safety
IEC 62353 sets out how medical electrical equipment in use is tested for safety. We test every unit before dispatch and after every repair, and attach the record to the device serial.
Unique device identification
UDI lets every device be identified throughout its life. We capture UDIs at receipt and pass them to your asset register, which makes recalls and audits faster.
Data security
Our customer portal and asset data are covered by a SOC 2 Type II report. Devices that store patient data are handled according to your instructions and our business associate agreement.
Documents
Policies on request.
Signed copies are available to customers and tender teams.
Bring us your next audit.
We will send the certificates and records your auditors ask for, organized by site.