Quality & Refurbishment Assurance

Purpose of This Framework

This Quality & Refurbishment Assurance Framework defines the technical, operational and compliance standards applicable to all refurbished medical equipment listed or supplied through MaxMed Systems.
It is designed to provide full transparency to healthcare providers, clinical operators and procurement departments regarding:

• equipment origin and traceability
   
• refurbishment levels and methodologies
   
• technical verification and acceptance testing
   
• configuration disclosure
   
• compliance boundaries and limitations
   
• supplier responsibility and contractual obligations
   

This framework is aligned with EU expectations for refurbished medical equipment and with industry practices adopted by leading European refurbishers.

Equipment Origin and Traceability

All equipment marketed through MaxMed Systems originates exclusively from:

• EU hospitals, private clinics or authorised medical operators, or
   
• certified EU refurbishers with documented quality protocols.
   

Each unit is supplied with:

• equipment identification (model, series, year, configuration)
   
• verification of prior use (where available)
   
• traceability of the refurbishment provider
   
• documentation of hardware and software configurations
   

MaxMed Systems does not source equipment from unknown, unverified or non-EU channels.

Refurbishment Levels (EU Refurbishment Tiers)

Refurbishers supplying equipment to MaxMed Systems may apply one or more of the following refurbishment tiers. The applicable tier depends exclusively on supplier inventory and may vary by model:

Tier 1 – Technical Refurbishment

• inspection, functional testing and calibration
   
• replacement of defective or end-of-life components
   
• software updates (where permitted)
   
• basic cosmetic adjustments
   

Tier 2 – Clinical-Grade Refurbishment

• full functional testing and recalibration
   
• detector/scanner component verification
   
• probe condition reporting (ultrasound)
   
• cleaning and decontamination to clinical standards
   
• partial cosmetic restoration
   

Tier 3 – Advanced Refurbishment

(typically applied to high-value systems such as CT/MRI)

• advanced hardware replacement (tubes, coils, detectors as available)
   
• mechanical, electrical and imaging performance verification
   
• cosmetic refurbishment
   
• acceptance testing reports from the refurbisher
   

MaxMed Systems discloses the refurbishment level only when the supplier provides formal documentation.

Technical Verification and Performance Testing

All refurbished systems supplied through MaxMed Systems are accompanied by:

• supplier-issued functional test reports
   
• performance verification results
   
• detector, probe or coil condition data (where applicable)
   
• documented system configuration and installed options
   

Testing methodologies may include:

• imaging performance tests (CT/MRI/DR/US)
   
• calibration of detectors, tubes and generator units
   
• noise and uniformity checks
   
• mechanical and motion integrity tests
   
• processor and optics evaluation (endoscopy)
   

MaxMed Systems does not alter or modify supplier tests.
We provide the documentation as received, ensuring transparency and traceability.

Installation, Commissioning and Acceptance

Installation and applications training are performed exclusively by the certified supplier technicians, not by MaxMed Systems.

Responsibilities include:

• site readiness assessment (where applicable)
   
• system installation and integration
   
• acceptance testing and performance validation
   
• applications training for clinical staff
   

The acceptance protocol is issued by the supplier and signed directly with the customer.

Limitations and Customer Responsibilities

As a remarketer and intermediary (not a refurbisher), MaxMed Systems:

• does not perform refurbishment activities
   
• does not provide equipment warranties or performance guarantees
   
• does not offer maintenance, repair or calibration services
   

Customers are responsible for:

• verifying clinical suitability
   
• ensuring regulatory compliance in their jurisdiction
   
• arranging operational maintenance and servicing contracts
   
• conducting local acceptance testing as required by national law
   

Where available, supplier warranty or service contracts may be facilitated but are not issued by MaxMed Systems.

Compliance With EU Medical Device Regulations

Refurbished medical equipment is governed by multiple frameworks depending on:

• device category
   
• configuration
   
• country of installation
   
• refurbishment level
   
• regulatory requirements for second-hand devices
   

MaxMed Systems operates strictly within the role of intermediary and does not place medical devices on the EU market as a manufacturer under the MDR.
Clients are responsible for verifying local clinical compliance requirements before commissioning the equipment.

Environmental and Sustainability Considerations

Refurbished medical systems extend equipment lifecycle and reduce:

• electronic waste
   
• energy-intensive manufacturing cycles
   
• disposal and replacement costs
   

This framework supports EU sustainability goals by promoting responsible reuse without compromising transparency or technical standards.

Supplier Accountability and Auditability

All refurbishers supplying equipment through MaxMed Systems must adhere to:

• documented technical processes
   
• transparent reporting
   
• fair-trade and ethical sourcing
   
• non-conflict and non-sanctioned procurement requirements
   

MaxMed Systems reserves the right to cease collaboration with any supplier failing to meet these standards.

Disclaimer

MaxMed Systems acts solely as an independent intermediary.
All refurbishment work, technical verification, installation, commissioning and servicing are performed exclusively by the original supplier or an authorised partner.

MaxMed Systems makes no representation or warranty regarding clinical performance, imaging output, software functionality or regulatory conformity.

Effective Date: December 2025

MaxMed Systems – Refurbished Medical Equipment Division
Operated by THEDERMALFILLER S.R.L.