Quality & Regulatory Management

Brooklyn Park HQ, MN – Central manufacturing and regulatory support hub.

Enfield, CT – Development and manufacturing for complex Class II and III devices

Costa Rica, Coyol Free Zone – Large-scale production for clinical and commercial builds

Santa Clara, CA – Development and manufacturing for Class II and III devices

Other FDA-Registered facilities include Rock Hill (SC), Santa Clara (CA), and Brooklyn Park Novel Cath.

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Regulatory Strategy Development: We work with you to understand the intended use and indications early, preventing delays and rework.

Submissions & Documentation: Our experts assist with 510(k), PMA, and CE Mark submissions, ensuring technical documentation aligns with global standards.

Testing & Validation: In-house capabilities include functional testing, packaging and sterilization validation, and biocompatibility testing to meet regulatory requirements.

Class 7 and Class 8 cleanrooms support sterile builds for implantable devices, catheters, and wearables.

Cleanroom operations meet ISO 14644 standards, preventing contamination and ensuring compliance for sterile-use products.

Global Market Access: Cirtec supports 510(k) and PMA submissions for the US MDR/IVDR submissions for CE Markings for European markets, along with compliance for other OUS Regulatory body frameworks.

Lean, Six Sigma, and Kaizen methodologies reduce variability, optimize workflows, and eliminate waste.

Ongoing employee training ensures our teams are ready to meet changing regulatory demands and best practices.

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Supplier qualification, audits, and continuous monitoring ensure consistent material and component quality.

ISO 14971-based risk management identifies potential hazards early to avoid disruptions in production.

eDHR systems provide traceability across the supply chain, enhancing operational visibility and compliance

IQ, OQ, and PQ validations verify that systems and equipment are ready for full-scale production.

In-process inspections and functional testing identify issues early to avoid costly rework and delays.

Packaging and sterilization validation ensures products maintain integrity and sterility through distribution and storage.

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DHF, DMR, and DHR records provide complete traceability from raw materials to delivery.

Automated document control helps to ensure version consistency and seamless regulatory audits.

eDHR systems support real-time data capture, ensuring production stays aligned with regulatory requirements.