Quality
IRP Medical strives to exceed our Customers’ expectations of Safety, Quality, Value, and Service by continuously improving our Quality Management System (QMS) and complying with relevant regulatory requirements.
Quality
IRP Medical strives to exceed our Customers’ expectations of Safety, Quality, Value, and Service by continuously improving our Quality Management System (QMS) and complying with relevant regulatory requirements.
How We Exceed Expectations
ISO 13485:2016 Certified & FDA Registered
QMS integrated into ERP system
QA Lab inside ISO 8 Clean-Room
3D Stereo Microscopes for Visual Inspection
FAIR/MSA/DOE/IQ/OQ/PQ Validations
Complete Material and Product ID & Traceability
Modern Automated non-contact Vision Metrology equipment
Strict compliance to applicable Regulatory requirements
Statistical Data Analysis of CTF (Critical-To-Function) dimensions to demonstrate Process Capability
Tighter AQL C=O Acceptance Sampling practices to maintain the highest degree of Lot-to-Lot Acceptance
Functional Testing such as Inflation Test for Lot Release, Rebound & Response Test, Leak Test
How We Exceed Expectations
ISO 13485:2016 Certified
QMS integrated into ERP system
QA Dept. inside ISO 8 Clean-Room
3D stereo microscope visual inspection
FAIR/MSA/DOE/IQ/OQ/PQ
Complete material and product traceability
Modern automated non-contact metrology equipment
Strict compliance with regulatory requirements
Statistical data analysis of CTF (Critical-To-Function) dimensions to demonstrate a capable process
Tighter AQL C=0 Acceptance Sampling practices to maintain the highest degree of lot-to-lot acceptance
Functional Testing
Tests for Leak, Inflation, Rebound, and Response