Pre-owned & Refurbished Suppliers

What are Pre-owned & Refurbished Surgical Robots?

Pre-owned and refurbished surgical robotics are previously used robotic systems that have been restored to full working condition for resale or reuse. Pre-owned and refurbished surgical robotic systems are typically sourced from hospitals or surgical centers that upgrade to newer models. 

Refurbishment involves thorough inspection, replacement of worn parts, software updates, and rigorous testing to meet original performance standards. Offering a more cost-effective option than new systems, they allow smaller medical facilities to access advanced robotic surgical technology without compromising safety or functionality. 

Pre-owned and refurbished surgical robots also contribute significantly to environmental sustainability. By extending the life of existing surgical robotic systems, they reduce electronic waste, minimise the need for new raw materials, lower carbon emissions associated with manufacturing, and support a model focused on reuse and resource conservation.

What Are Some Examples of Pre-owned & Refurbished Surgical Robots?

The following list includes pre-owned & refurbished surgical robots commonly used across various surgical robotic applications:

General Surgical Robotics

•  Systems that are widely used for minimally invasive procedures across urology, gynaecology, thoracic, and general surgery.

Orthopaedic Robotics

•  Surgical robots used for joint replacements, offering precise bone preparation and implant placement.

Spinal Robotics

•  Systems that help with spinal fusion and other complex spinal surgeries, providing enhanced accuracy in screw placement and alignment.

Endoscopic/ENT Robotics

•  Platforms that assist in lung and urology procedures, offering advanced visualisation and control during endoscopic surgeries.

Laparoscopic Hybrid Systems

• Robotic systems that combine traditional laparoscopy with robotic assistance offering more flexible and cost-effective options.

What Are the Regulatory Compliance Requirements for Pre-owned & Refurbished Surgical Robots?

Pre-owned and refurbished surgical robots must meet the same regulatory standards as new devices to ensure safety and effectiveness. In many regions, including the U.S. and EU, refurbished systems must comply with applicable medical device regulations such as FDA 21 CFR Part 820 (Quality System Regulation) and ISO 13485. 

The refurbishing company is typically responsible for documenting that the pre-owned surgical robot performs to original specifications, including risk management, validation, and traceability.

Regulatory bodies may require re-registration or approval, especially if major components are replaced or software is modified. Clear labeling, service history, and proper quality assurance are critical for regulatory acceptance and clinical use of pre-owned & refurbished surgical robots.

What Standards Do Pre-owned & Refurbished Surgical Robots Need to Meet?

To ensure compliance and patient safety, pre-owned & refurbished surgical robots must meet a range of critical regulatory and quality standards, including the following key certifications and requirements:

ISO 13485 – Medical Devices Quality Management System

• Ensures that the organisation refurbishing pre-owned & refurbished surgical robots follows a quality management system tailored to medical devices. It covers processes like risk management, traceability, and documentation.
  

FDA 21 CFR Part 820 – Quality System Regulation (QSR)

• U.S. regulation requires manufacturers (and refurbishers) of pre-owned surgical robots to establish and maintain a quality system for medical devices, including design controls, production processes, and corrective actions.
  

ISO 14971 – Medical Device Risk Management

• Often required when a pre-owned surgical robot has undergone major changes, it provides a framework for identifying and managing risks throughout the device’s life cycle, including during refurbishment, to ensure continued safety and effectiveness.
  

IEC 60601-1 – Medical Electrical Equipment: General Requirements for Safety

• Ensures the electrical and mechanical safety of medical devices, including refurbished surgical robots. Covers things like electrical shock protection and mechanical hazards. Only required if the electrical or mechanical systems are changed or if the original safety certification is no longer valid.
  

MDR (EU 2017/745) – Medical Device Regulation (EU only) 

• European regulation governing the safety and performance of medical devices. Any pre-owned & refurbished surgical robot placed on the EU market must comply with MDR, which may require recertification or additional approvals.
  

ISO 10993 – Biocompatibility of Medical Devices

• If the refurbished robot includes parts that contact the patient, this standard ensures materials are safe and compatible with biological tissues.