Quality & Regulatory Credentials

Certifications

Monobind manufactures diagnostic products within an established quality management system supported by recognized certifications, regulatory registrations, controlled manufacturing processes, and product traceability.

Quality You Can Verify

ISO

ISO 13485 Certified

Medical Device Quality Management

Monobind maintains a certified quality management system designed to support the consistent development and manufacture of medical devices.

View ISO 13485 certificate

CE

CE-Marked Products

Current European Market Status

Monobind maintains CE marking for applicable products placed on the European market under current regulatory provisions.

IVDR

IVDR Transition in Process

European Regulatory Program

Monobind is actively progressing its transition activities under the European In Vitro Diagnostic Medical Devices Regulation.

Regulatory status: Certification, registration, CE-marking, and IVDR transition status may vary by product and market. Contact Monobind for documentation or regulatory information relating to a specific product.

California Manufacturing

Controlled Production from Receipt Through Release

Monobind manufactures its products in a 40,000+ square-foot facility in Lake Forest, California. Operations are supported by controlled procedures, qualified materials, production records, in-process quality controls, batch review, and final product release.

The facility supports scalable diagnostic manufacturing while maintaining the documentation and controls required for consistent product quality.

Quality Infrastructure

Integrated Systems and Traceability

  • Raw-material qualification
  • Lot-number assignment
  • In-process quality control
  • Batch analysis
  • Controlled documentation
  • Final product release
  • Product identification
  • Lot-level traceability

Quality in Practice

Systems Supporting Consistent Product Quality

Quality Management

Documented procedures, training, internal review, corrective and preventive actions, supplier controls, and management oversight support Monobind's Quality Management System.

Regulatory Compliance

Regulatory and technical documentation is maintained to support applicable registrations, product status, international distribution, and market-specific requirements.

Manufacturing Controls

Qualified materials, controlled production records, component identification, process checks, quality-control testing, and final release review support consistent manufacturing.

45+ YearsDiagnostic Experience
40,000+Square-Foot Facility
100+Countries Served
ISO 13485Certified Quality System

Our Commitment to Quality

Read how Monobind approaches customer satisfaction, regulatory compliance, employee responsibility, and continual improvement.

View quality policy

Need Quality or Regulatory Documentation?

Contact Monobind for assistance with certificates, regulatory documentation, product-specific status, distributor requirements, or quality-related inquiries.

Contact Monobind