Regulatory-Ready Manufacturing With Absolute Traceability
Perfect for medical devices, surgical tools, diagnostic equipment & precision machining.
Common Challenges in Medical Device Manufacturing
Regulatory requirements and quality standards create unique operational challenges
Documentation-Heavy Audits
Extensive paperwork requirements for regulatory compliance create administrative burden
Zero-Tolerance Quality Expectations
Medical device manufacturing demands absolute precision with no room for error
Strict QC at Each Stage
Multiple quality checkpoints throughout production slow down workflows
Instrument Calibration Required
Regular calibration and certification of measuring instruments is mandatory
Traceability Must Be Flawless
Complete device history record (DHR) tracking from raw materials to final product
Complex Batch Management
Managing lot numbers, serial numbers, and batch records is extremely challenging
Solutions With Fleek ERP
Purpose-built for medical device and precision engineering manufacturers
QC Documentation at Every Stage
Automated documentation ensures audit-ready records at all times
Auto Fail/Pass Based on Tolerance
Instant validation against specifications with automated decision-making
Device-Level Traceability
Complete visibility from raw materials to finished product
Calibration Management
Automated tracking and alerts for instrument calibration
Root Cause Analysis Tools
Defect → stage → operator mapping for quick issue resolution
- Defect source identification
- Stage-wise failure analysis
- Operator performance correlation
Audit-Ready Documentation
Complete DHR (Device History Record) with instant access
- Digital batch records
- Electronic signatures (21 CFR Part 11)
- Instant report generation
Why You Should Use Fleek ERP
Medical Edition - Built for manufacturers who demand regulatory excellence
Meets ISO 13485, FDA 21 CFR, GMP Requirements
Built-in compliance features ensure adherence to global regulatory standards
Eliminates Documentation Errors
Automated record-keeping reduces manual errors and ensures accuracy
Ensures 100% Traceability
Complete device history record with full component-level tracking
Reduces Audit Time Drastically
Audit-ready documentation available at the click of a button
Improves Product Reliability
Stringent quality controls ensure consistent high-quality output
Customer Trust & Confidence
Demonstrable compliance and quality records build customer confidence
Root Cause Analysis
Quick identification of defect sources with comprehensive data mapping
Calibration Compliance
Never miss calibration deadlines with automated alerts and tracking
Meet Global Quality Standards With Ease — Book Consultation
Join leading medical device manufacturers who trust Fleek ERP for regulatory compliance and quality excellence