QUALITY AND REGULATORY

SAFETY. QUALITY. EXCELLENCE.

We foster a culture of continuous improvement with a quality management system focused on defect prevention, customer satisfaction, and exceeding quality and regulatory compliance.

COMMITTED TO QUALITY. COMMITTED TO YOU.

Our goal is to provide customers and consumers with the highest quality products by assuring their 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 certified to ISO 13485:2016 and ISO 9001:2015.
  • Our US FDA Drug Master Files (DMF) are available for quick reference.
  • Comar’s entire dosage delivery device portfolio is CE certified.
  • We have seasoned and diverse regulatory support available to ensure that your pharmaceutical, healthcare, or food safety products continuously meet regulatory expectations.

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 product 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) scan
  • Fourier-transform infrared spectroscopy (FT-IR)
  • Optical comparator
  • Laser micrometers
  • Force testing instrumentation
  • UV/visual spectrophotometry
  • Light transmission densitometer
  • High-speed leak testing

To address custom applications, we can also develop specialized testing equipment and approaches.

ISO Certifications

All our facilities are certified to ISO 13485 or ISO 9001 to deliver exceptional products with the quality you expect.

View our certifications

OTHER CAPABILITIES

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