Our Services
TedMed Engineering Projects (TMEP) Consulting Services
– Projects We Manage
Medical Affairs Support
We bridge science, regulatory, and commercial teams.
Services include:
• Clinical evaluation planning
• Post-market clinical follow-up (PMCF)
• Scientific literature review
• Safety documentation support
• Medical writing & clinical documentation
Outcome: Scientifically supported regulatory positioning.
Clinical Project Management
We manage clinical research operations with compliance and efficiency.
Services include:
• Phase I–IV oversight
• Trial master file (TMF) management
• Vendor coordination
• Risk-based monitoring
• GCP compliance oversight
• Budget and timeline management
Outcome: Controlled, compliant, milestone-driven clinical execution.
Quality Control
We support product and process monitoring to maintain consistent performance.
Services include:
• Statistical Process Control (SPC)
• Incoming & final inspection systems
• Laboratory quality systems
• Deviation management
• Root cause investigations
• Batch record review
Outcome: Controlled manufacturing processes with measurable quality metrics.
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
Regulatory Strategy Projects
We develop comprehensive regulatory pathways tailored to your product and target markets.
Services include:
• Product classification & pathway determination (510(k), PMA, IND, NDA, BLA)
• Global regulatory strategy (US, EU, UK, Canada)
• Gap analysis & remediation planning
• Regulatory intelligence & competitive landscape analysis
• Pre-submission meeting support (FDA Q-Sub, Pre-IND)
Outcome: Clear regulatory roadmap with minimized approval risk.
Regulatory Submissions Projects
We prepare and manage complete submission packages with precision and traceability.
Medical Devices:
• 510(k), De Novo, PMA
• EU MDR Technical Documentation
• Clinical Evaluation Reports (CER)
• Software validation documentation
• Risk management files
Drugs & Biologics:
• IND preparation
• NDA/BLA submission
• eCTD publishing
• CMC documentation support
Outcome: Audit-ready, regulator-aligned submissions.
Quality Assurance Projects
We implement and optimize Quality Management Systems that align with global standards.
Standards Supported:
• 21 CFR Part 820
• ISO 13485
• ISO 14971
• ICH Q8–Q10
• GMP / GLP / GCP
Services include:
• QMS development & remediation
• Internal audits
• SOP development
• CAPA management
• Inspection readiness support
Outcome: Sustainable compliance infrastructure.
Validation Engineering Projects
We ensure systems, processes, and equipment perform as intended.
Validation Expertise:
• IQ / OQ / PQ
• CSV (Computer System Validation)
• Software validation (IEC 62304 alignment)
• Process validation
• Cleaning validation
• Equipment qualification
Outcome: Documented evidence of performance and regulatory. compliance.
Get a Quote
Tell us about your project for a quote.