Polyzen's Commitment to Quality

At Polyzen, quality is at the core of everything we do. Every member of our team is committed to delivering the highest levels of product quality and reliability with unmatched consistency. Our facility is ISO 13485:2016 and ISO 9001:2015 certified, and we have all of the personnel and infrastructure in place to ensure ongoing compliance for development and manufacturing of Class I, II, and III devices. This includes quality systems, document controls, and process controls needed to develop, produce, inspect, test, validate, and deliver medical devices and components.

Regulatory Compliance & Quality Management

Polyzen is dedicated to the current good manufacturing practices (cGMP) of medical devices as defined by the FDA. Our regulatory team maintains a robust quality management system (QMS) through internal audits, preventative action programs, and business and management review meetings. We use careful documentation and dedicated oversight to ensure the highest level of quality expected by our customers and partners.

Our commitment to the medical device industry is reflected in our investment in process verification and validation resources to support design validations for customer products. This includes process equipment, analytical equipment, skilled quality personnel, and management support.

Accreditations

ISO 9001 Since 1999
ISO 13485 Since 2006
FDA Registered (QSR 21, CFR Part 820)
GMP Compliant for Phase 1 Investigational Drug/Device Combination Products
Japan: MHLW Ministerial Ordinal 169

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