Quality & Certifications

Quality is the foundation of everything we do at Pliant Medical.

Certifications

Pliant Medical is committed to delivering the highest levels of quality, consistency, and regulatory compliance across every medical program. Our robust quality management system, industry-recognized audits, and globally trusted certifications ensure that every component we produce meets the rigorous standards required for medical and pharmaceutical applications.

ISO 13485

Certification Coming in 2026

Cleanroom Classification Levels

To support sensitive medical molding and assembly programs, Pliant operates controlled cleanroom environments engineered for precision, sterility, and regulatory compliance. These ISO-certified spaces enable us to manufacture and assemble components with strict particle-count control, ensuring product integrity from start to finish.

Class 7 - ISO 10K Injection Molding

Advanced Molding Capabilities Ranging From 17 to 250 Tons

Class 7 - ISO 10K Assembly Cleanroom

Precision Assembly in a Controlled Environment

Performance Metrics

Pliant Medical delivers world-class quality and dependable on-time performance by anticipating end-user needs, focusing on creating the best possible products, and achieving the highest levels of customer satisfaction—without compromise.

Quality

Our quality policy—Delight the Customer—empowers every team member to make decisions that support exceptional outcomes, as reflected in our consistently high quality scores across all customers.

Delivery

Operating at 99.994% on-time delivery, we set ourselves apart from other medical manufacturers.

ISO 13485 Timeline

Pliant Medical is currently scheduled to have full ISO 13485 certification by October of 2026.