IRP strives to exceed our Customer’s expectations of Quality, Value and Service by continuously improving our Quality Management System and complies to relevant regulatory requirements.

Quality Systems
• ISO 13485:2003 Certified
• ISO 9001:2008 Certified
• QMS integrated into IRP’s ERP system
• QA inside ISO8 Clean-room
• Non contact vision inspection
• Nikon VMA-2520
• 4 X Vision Engineering Mantis Scopes (8X, 10 X & 15X)
• Optical Comparator
• Functional Testing
• FAIR/IQ/DOE/OQ/PQ Validations 

CLICK HERE TO VIEW OUR FDA REGISTRATION NUMBER

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In the medical device industry, component quality is not only critical to product performance, it
can also mean the difference between life and death. This is why manufacturers of class I and
class II devices turn to IRP Medical’s line of medical grade elastomers and tight tolerance silicone
components for their medical device needs. IRP Medical rubber products are designed,
engineered and manufactured under strict cGMP conditions to ensure bio-compatibility and
performance reliability. With Class 100,000, ISO 9001:2000 clean rooms in both the United States
and China, IRP can deliver top-quality, precision molded components with reduced landed costs
to customers worldwide. Projected ISO-13485 certification: Winter 2007.

Medical-grade elastomer products produced by IRP Medical include:

Seals • Diaphragms • Check Valves • Peristaltic Pump Tubes • Bellows • Boots.

To meet its customers’ varied challenges, IRP Medical can manufacture products using
a variety of molding processes, including:

Heat cured (gum) injection molding • Liquid silicone (LIM) injection molding • Transfer Molding
Rubber-to-substrate bonding including metal, Teflon® and plastic • Compression Molding

IRP Medical specializes in medical grade silicone products as well as labor intensive medical device sub-assemblies.