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Medical Device Servicing 

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Medical device servicing involves the repair, calibration, inspection, and preventive maintenance of medical equipment after it has been distributed and placed into use. The goal is to ensure that each device continues to meet its original safety, quality, and performance specifications throughout its lifecycle.

 

At TedMed Engineering Projects (TMEP) Consulting, we provide comprehensive servicing support to healthcare facilities, laboratories, and life-science organizations to maintain equipment reliability, protect patient safety, and ensure regulatory compliance.

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Key Aspects of Medical Device Servicing

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​​The U.S. FDA defines servicing as maintaining, or repairing a finished device, so it continues to perform according to its original intended use and safety specifications.

Preventive & Corrective Maintenance

• Routine inspections and scheduled servicing to prevent equipment failure

• Troubleshooting and repair of malfunctioning devices

• Replacement of worn or defective components

• Performance verification and functional testing

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Regulatory Importance

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Proper device servicing supports compliance with quality and regulatory standards such as:

• ISO 13485 Quality Management Systems

• FDA Quality System Regulation (21 CFR Part 820)

• Hospital accreditation and safety requirements

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TMEP Consulting partners with healthcare organizations to support compliant, documented, and audit-ready servicing programs.

 

Servicing vs. Remanufacturing

Servicing restores equipment to its original performance condition.

Remanufacturing, however, involves significant changes to a device’s safety or performance specifications and requires additional regulatory oversight.

 

 Services Offered by TedMed Enginnering Projects (TMEP Consulting)

 

Field Service & Repair

• On-site diagnostics and repairs

• Support for imaging systems, laboratory equipment, and clinical devices

• Emergency breakdown response

Preventive Maintenance Programs

• Scheduled maintenance planning

• Inspection and performance verification

• Compliance documentation and reporting

 

Calibration Services

• Accuracy verification for diagnostic and laboratory equipment

• Traceable calibration documentation

• Compliance with quality standards

 

Asset & Equipment Lifecycle Management

• Equipment inventory tracking

• Service history documentation

• Replacement planning and utilization optimization

Digital & Remote Support Solutions

• Remote diagnostics and troubleshooting

• Data-driven maintenance planning

• Technology-enabled service support

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Why Medical Device Servicing Matters

• Protects patient safety

• Extends equipment lifespan

• Ensures regulatory compliance

• Reduces downtime and operational costs

• Maintains clinical performance accuracy

 

For maximum safety and reliability, servicing is performed by our qualified biomedical engineers, OEM-trained technicians, or certified service providers.

 

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​Medical Equipment Calibration, Maintenance, and Asset Management projects​​​​​​​​

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Medical equipment must comply with FDA regulations, ISO 13485, ISO 17025, and hospital biomedical engineering standards.

TedMed Engineering Projects ( TMEP Cnnsulting) manages all the  Key Phases of our Equipment Service Projects

 

Planning & Initiation

    •    Define project objectives (e.g., install new MRI scanner, replace old infusion pumps, validate lab analyzers).

    •    Identify scope, stakeholders, and regulatory requirements.

    •    Assess facility readiness (power, network, space, safety).

    •    Develop project plan — schedule, resources, and risk management.

Deliverables:

    •    Project Charter

    •    Service Plan / Statement of Work (SOW)

    •    Risk Assessment (per ISO 14971 )

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Procurement & Logistics

    •    Source equipment, spare parts, and tools.

    •    Manage vendor coordination and service contracts.

    •    Plan shipment, storage, and inventory tracking.

 

Deliverables:

    •    Procurement plan

    •    Vendor qualification documentation

    •    Equipment receipt inspection checklist

 

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 Installation & Commissioning

    •    Oversee on-site installation, ensuring safety and technical accuracy.

    •    Conduct Installation Qualification (IQ) and Operational Qualification (OQ).

    •    Validate performance (Performance Qualification – PQ).

    •    Train end users and service staff.

 

Deliverables:

    •    IQ/OQ/PQ reports

    •    Installation checklist

    •    Training certificates

 

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Maintenance & Lifecycle Management

    •    Develop and implement preventive maintenance schedules.

    •    Manage calibration and certification per manufacturer and regulatory guidelines.

    •    Record all service events for audit readiness.

    •    Track MTBF (Mean Time Between Failures) and MTTR (Mean Time to Repair) for performance metrics.

 

Deliverables:

    •    Service logs

    •    Calibration certificates

    •    Maintenance reports

 

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 Decommissioning or Upgrades

    •    Plan safe disposal or recycling per environmental standards.

    •    Validate system data backup and transfer.

    •    Document decommissioning process and asset tracking.

 

Deliverables:

    •    Decommissioning report

    •    Asset removal documentation

 

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🧠 Core Skills & Competencies

 

Category  :  Key Skills

Technical :   Equipment installation, calibration, validation, root cause analysis.

Project Management  :  Scope, scheduling, budgeting, stakeholder and vendor management.

Regulatory/Quality :   FDA 21 CFR Part 820, ISO 13485, ISO 9001, ISO 17025, GMP compliance.

Safety & Risk Management :   Environmental Health & Safety (EHS), risk assessments, CAPA processes.

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🧰 Tools & Systems we use:

    •    Project Management: MS Project, Smartsheet, or Asana 

    •    Service Management: SAP, Oracle CMMS, ServiceMax, or Salesforce Field Service.

    •    Quality Documentation: eQMS systems and MasterControl.

    •    Reporting: Power BI or Tableau dashboards for service metrics.

 

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📈 Example: Hospital MRI Installation Project

 

Objective: Install and validate a new MRI system in a hospital.

 

Steps:

    Plan logistics — delivery, site prep, power requirements.

    Coordinate with vendors, radiology department, and facilities.

    Manage installation, IQ/OQ validation, and safety checks.

    Train operators and maintenance staff.

      Document everything for audit and compliance.

 

KPIs:

    •    Installation completed on schedule

    •    Zero safety incidents

    •    IQ/OQ/PQ acceptance on first pass

    •    Customer satisfaction > 95%

 

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