TEDMED Engineering Projects (TMEP Consulting)
Medical Equipment Management
Medical Device Service
Medical Device Repair.
We manage all kinds of medical devices repairs.
Preventive Maintenance
We perform quarterly and annual PM to fix issues and prevent equipment breakdown.
Clinical Research Equipment Validation Project
We manage validation projects. We oversee the validation deliverables provide validation compliance stickers, and a service report to present to CRA's and other auditors.
Medical Device Installation Projects.
Call us to manage your installs, and testing of all your medical devices and validation.
Medical Device Qualification
Call us to qualify your units, to meet regulatory compliance.
GMP IQOQIPV / PQ Projects
We manage Installation qualification, operational qualification, installation operational verification and process qualification of all laboratory equipment at GMP sites.
Medical Device Development and Medical Device Service Project Management
Medical device Development Project Management​
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Medical Device Project Management involves leading and coordinating the development of medical devices from concept to market while ensuring compliance with regulatory standards (like FDA, ISO 13485, and MDR). It’s a highly structured, cross-functional discipline requiring both technical understanding and regulatory expertise.
Here’s a breakdown of what we provide as for our clients:
1. Project Initiation & Planning
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Define project scope: What problem does the device solve? What are its intended use and target markets?
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Develop project charter: Objectives, budget, timeline, and stakeholders.
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Assemble the team: Includes R&D, quality assurance, regulatory affairs, clinical, manufacturing, and marketing.
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Risk management planning: In line with ISO 14971 for medical device risk management.
2. Design & Development Phase
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Design controls: Following FDA 21 CFR 820.30 or ISO 13485:2016, documenting every stage from user needs to final design verification and validation (V&V).
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Design inputs: User requirements, clinical needs, and regulatory constraints.
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Design outputs: Specifications, drawings, software code, etc.
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Design reviews: Formal checkpoints to ensure quality and compliance.
3. Verification & Validation
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Verification: Ensures the device meets design specifications.
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Validation: Confirms it meets user needs and intended uses, often involving clinical evaluations or trials.
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Traceability matrix: Links user needs → design inputs → verification → validation results.
4. Regulatory & Quality Compliance
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Regulatory strategy: Identifies submission pathways (e.g., FDA 510(k), De Novo, PMA, or EU MDR CE marking).
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Quality management system (QMS): Must comply with ISO 13485 and FDA QSR (21 CFR Part 820).
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Documentation: Design history file (DHF), device master record (DMR), and device history record (DHR).
5. Manufacturing & Transfer
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Process validation: Ensures consistent, compliant manufacturing.
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Supplier management: Qualified and compliant suppliers under QMS.
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Pilot production & scale-up: Test production before full release.
6. Market Launch & Post-Market Surveillance
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Regulatory approval: Obtain necessary clearances/approvals.
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Launch planning: Coordinate marketing, distribution, and training.
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Post-market monitoring: Track complaints, adverse events, and field actions (per ISO 13485:2016 Clause 8).
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Continuous improvement: Feed post-market data back into design updates.
7. Key Roles: Our Subject Master Expertise
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Project Manager
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Regulatory Affairs Specialist
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Quality Engineer
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Design Engineer
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Clinical Affairs Manager
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Manufacturing Engineer
8. Tools & Methodologies
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Project management frameworks: Waterfall for regulatory-heavy projects; Agile for software-based devices.
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Software tools: MS Project, Jira, Trello, or specialized tools like Greenlight Guru or MasterControl etc.
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Risk management: FMEA (Failure Modes and Effects Analysis), fault tree analysis.
Medical Device Service Project Management
Equipment Service Project Management involves planning, coordinating, and overseeing service projects for new or existing equipment.
That includes:
• Installation & commissioning of new systems
• Preventive and corrective maintenance
• Upgrades, calibration, and validation
• Decommissioning and replacement
In a medical device or hospital context, these projects must also comply with FDA regulations, ISO 13485, ISO 17025, and hospital biomedical engineering standards.
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🧠Key Phases of our Equipment Service Projects
1. 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 if medical device-related)
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2. 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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3. 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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4. 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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5. 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.
Communication Coordination with hospitals, OEMs, and technical teams.
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🧰 Tools & Systems Used
• Project Management: MS Project, Smartsheet, or Asana etc.
• Service Management: SAP, Oracle CMMS, ServiceMax, or Salesforce Field Service etc.
• 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:
1. Plan logistics — delivery, site prep, power requirements.
2. Coordinate with vendors, radiology department, and facilities.
3. Manage installation, IQ/OQ validation, and safety checks.
4. Train operators and maintenance staff.
5. 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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🎓 TMEP Project Engineers Education & Certifications
• Education: Engineering, Biomedical Engineering, or Technical Management.
• Certifications:
• PMP (Project Management Professional)
• Certified Biomedical Equipment Technician (CBET)
• Lean Six Sigma
• ISO 13485 or 9001 Auditor Certification
• EHS / OSHA Training
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