Our Services
Training and Implementation
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ISO 13485:2016 & ISO 9001:2015
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Environmental Management System (EMS)
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Health & Safety Management System
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Food Safety Management System
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Social Accountability Management System
Turnkey Project Process Flow – Medical Devices
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Project Initiation & Feasibility
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Facility Planning & Layout Design
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Regulatory Strategy & Approvals
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Documentation Development
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Procurement & Installation
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Validation & Qualification
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QMS Implementation
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Regulatory Submission
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Audit & Inspection Support
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Commercial Launch
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Post-Market Compliance
Process Flow – Retainership Model
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Onboarding & Requirement Assessment
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Gap Analysis & Compliance Roadmap
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QMS Maintenance & Implementation Support
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Regulatory Compliance Management
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Training & Awareness Programs
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Internal Audits & Mock Inspections
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Management Review & Reporting
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Continuous Improvement & Updates
Licensing, Certification & Regulatory Support
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Licensing & Certification Assistance
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ISO 13485, 21 CFR 820, CDSCO Compliance
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Internal Audits & Regulatory Audit Support
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EU MDR Training & Compliance Support
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US FDA – Part 21 CFR Compliance Support
Business Excellence & Quality Improvement
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Business Excellence Model Support (EFQM, Malcolm Baldrige Model)
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Six Sigma / Lean Six Sigma Training & Implementation
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Total Quality Management (TQM) Training & Implementation
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Training on Quality Tools including:
Statistical Process Control (SPC)
Failure Mode and Effects Analysis (FMEA)
Design of Experiments (DOE)