QUALITY AND REGULATORY

High Performance. High Quality.

Quality is core to who we are and what we do. We strive to provide products that are flawless in their intended use and “right the first time,” raising the bar on expectations.

EXCELLENCE IS EXPECTED

Our goal is to manufacture high-quality products that deliver superior performance, consistency, safety, and value.

Comar Quality Policy

  • Integrity: We expect integrity of our people, our products, and our partners—this is our most important guiding principle.
  • Customer Satisfaction: We stand for high-quality, safe, and effective products and services.
  • Improvement: We are driven to continuously improve the effectiveness of our quality management system (QMS), our products, and our services.
  • Compliance: We proactively assess and align with the ever-evolving regulatory requirements that guide the markets and regions we serve.
  • Commitment: We commit to achieving our quality objectives—customer satisfaction, on-time delivery, and operating efficiency.

Quality Management Systems and Regulatory Compliance

We have designed our quality management system (QMS) to implement effective risk assessment and risk management to ensure compliance with customer and regulatory requirements. This creates a solid foundation to provide our customers with a reliable supply of high-quality products and services.

We are:

  • FDA registered
  • Certified to ISO 13485:2016
  • Certified ISO 7 and 8 Cleanrooms
  • Committed, through our internal audit and management review processes, to compliance with all relevant regulatory and statutory requirements, including but not limited to ISO 13485:2016, 21CFR211, and 21CFR820
  • CE mark certified for specific products as per European Union requirements
  • Utilizing robust verification and validation processes including DFM, DFA, dFMEA, pFMEA, IQ, OQ, and PQ

State-of-the-Art Metrology and Quality Inspection

Our ongoing investment in best practices and tools for metrology and inspection mitigates risk and guarantees consistent part quality. We have a variety of measurement systems to visualize; measure; and analyze internal components, surfaces, and complex geometries. We can also measure chemical, physical, and material properties. Our capabilities include the following:

  • Vision systems
  • Single- and multi-sensor coordinate measurement machines (CMM)
  • Computerized tomography (CT)
  • Fourier-transform infrared spectroscopy (FTIR)
  • Laser micrometers
  • Force testing instrumentation
  • Color spectrophotometry
  • High-speed leak testing
  • GR&R studies performed on all metrology equipment for critical dimensions
  • Custom jig and fixture creation

To address custom applications, we can also develop specialized testing equipment and approaches that facilitate your medical innovation.

ISO Certifications

Our medical manufacturing facilities are certified to ISO 13485 to help your project achieve the exceptional quality you expect.

View our certifications

Other Capabilities

SET YOUR POSSIBILITIES INTO MOTION

Experience the fresh thinking, engineering edge, and customer focus that helps you advance.

CONTACT US