Quality Assurance & Certification Standards

This Quality Assurance & Certification Standards Statement (“Statement”) defines the technical, regulatory and operational requirements applied by MaxMed Systems (“MaxMed”) in the sourcing, verification and delivery of refurbished medical equipment.
It is mandatory for all suppliers, refurbishers, logistics partners and associated technical service providers.

MaxMed operates under a strict compliance and quality governance framework aligned with EU medical, safety and refurbishment standards.

Regulatory Framework and Compliance Obligations

All equipment sourced and delivered through MaxMed must comply with:

• European Medical Device Regulation (MDR / EU 2017/745) where applicable
   
• Electrical safety standards (IEC / EN 60601 series)
   
• EMC (Electromagnetic Compatibility) standards for medical devices
   
• Manufacturer-required deinstallation and installation procedures
   
• National health technology regulations in the country of origin and destination
   

Refurbished equipment must retain full traceability to its original regulatory status.

Supplier and Refurbisher Qualification

Only suppliers meeting the following criteria may provide equipment to MaxMed:

• documented refurbishment processes audited or recognised within the EU
   
• certified technicians responsible for testing, calibration and configuration
   
• access to manufacturer-approved service tools where required
   
• verifiable track record in handling advanced imaging systems
   
• transparent ownership documentation for all equipment
   

MaxMed conducts independent verification of supplier compliance when necessary.

Technical Verification and Performance Documentation

Before delivery to the client, all refurbished equipment must undergo:

• functional testing according to manufacturer specifications
   
• safety testing under EN 60601 requirements
   
• detector, tube or coil performance verification for imaging systems
   
• calibration or correction procedures where required
   
• software version control and confirmation of licence status
   
• generation of a documented performance report, signed by a certified technician
   

MaxMed retains the right to request all test logs prior to shipment.

Deinstallation, Handling and Transport Standards

Deinstallation and transport must be executed under strict technical controls:

• equipment must be powered down, secured and deinstalled per manufacturer procedures
   
• cooling systems, magnets or sensitive components must be stabilised according to technical protocols
   
• shock, tilt and environmental protections must be applied during transport
   
• only approved medical transport or technical logistics providers may be used
   
• MRI systems require specialised handling, including cryogen management and magnetic field safety measures
   

Transport partners must maintain documented compliance with EU logistics standards.

Installation and Acceptance Protocols

Installation must be performed solely by certified technicians approved by the supplier.
The installation process must include:

• electrical safety verification
   
• mechanical and software configuration
   
• imaging tests and calibration
   
• suite compatibility assessment (power, ventilation, RF shielding where required)
   
• issue reporting and resolution prior to handover
   

Upon completion, a formal Installation & Acceptance Report must be generated.

Documentation Package Supplied to Clients

Each delivered system must include:

• technical performance report
   
• configuration and options summary
   
• deinstallation and installation documentation
   
• service history where available
   
• operator manuals, digital or printed (subject to supplier availability)
   
• warranty statement from the refurbisher or supplier
   

Documentation must be clear, complete and available in English.

Warranty and Post-Installation Support

Warranty is provided exclusively by the EU refurbisher or supplier delivering the equipment.
Warranty terms typically cover:

• parts and labour for defects not related to misuse or external factors
   
• replacement of major components depending on contract terms
   
• technical support and remote diagnostics
   

MaxMed does not perform on-site service; all service is executed by certified supplier technicians.

Continuous Quality Monitoring

MaxMed reviews supplier performance through:

• complaint tracking and resolution
   
• independent verification of refurbisher test procedures
   
• technical incident reporting and follow-up
   
• annual review of supplier compliance status
   

Suppliers failing to maintain required standards may be removed from the MaxMed network.

Liability Framework

MaxMed acts strictly as an intermediary in the sourcing and distribution of refurbished medical equipment.
Liability related to refurbishment quality, technical failure or warranty coverage resides with the certified supplier performing the refurbishment and installation.

MaxMed ensures transparency by providing:

• full supplier identification
   
• clear allocation of technical responsibilities
   
• documented warranty terms
   
• explicit contractual separation of obligations
   

MaxMed Systems – Refurbished Medical Equipment Division

Operated by THEDERMALFILLER S.R.L.
Effective Date: December 2025
Updated for 2026 EU Quality Assurance Standards