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Uniting Precision and Innovation for Medical Device Manufacturing.

Proven, world-class manufacturing operating at 97.5%

  • ISO 13485:2016 Compliant Manufacturing

Our Medical Device Manufacturing Process

We partner together with you to take your concept from innovation to validation. Operating in a fully ISO 13485:2016 facility, we will get you ready for FDA approval and produce at scale.

Verification & Validation

This process in the development of medical devices is a critical phase that ensures your products meet the highest standards of quality, safety and efficacy. How we verify and validate:

  • Rigorous testing of device components and subsystems to confirm they meet design specifications.
  • Verification of software integrity, including validation of software used in device operation.
  • Validation of manufacturing processes to ensure consistency and reliability in production.

Manufacturing

Our process of medical devices manufacturing is in accordance with ISO 13485:2016 standards, which means prioritizing quality, patient safety and compliance. What makes our manufacturing process different:

  • Stringent supplier selection and management to ensure the quality of raw materials and components.
  • Controlled manufacturing environments and processes to prevent contamination or defects.
  • Documented procedures for device assembly, testing, and inspection in line with ISO 13485:2016 requirements.

ISO 13485:2016 Product Prototyping

By directly collaborating with our customers, our cross-functional design team brings a conceptual product prototype through our engineering and design process. What makes our process different:

  • Application of advanced engineering principles to optimize device functionality and performance.
  • Emphasis on user-centered design principles to ensure intuitive and safe device operation.
  • Commitment to delivering high-quality, compliant, and innovative medical and point-of-care devices.

Application & Software Development

We support specific custom research applications to clinical assay support applications.

With decades of experience, we are able to transfer a methodology into an automated procedure using optimized hardware and software configurations. All under the QC requirements of ISO 13485:2016.

  • Hardware & Software Optimized
  • Complete Synchronization

Our Clients Over the Years

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Technical Support

We offer technical support on every level. Our processes ensure regulatory compliance, streamlining production for quicker time-to-market, optimizing processes for efficiency and quality, minimizing downtime through troubleshooting, and fostering continuous improvement and innovation.

ISO 13485:2016 Consulting

We work closely with our clients to assess their current product quality management system compliance, identify gaps and develop tailored strategies for product compliance.

This helps our clients navigate the complexity of quality management and regulatory compliance, ultimately contributing to the delivery of high-quality, safe and effective point-of-care medical devices and consumables to healthcare providers.

Ready to turn your medical device concept into reality?
LET’S WORK TOGETHER
About Calibrex Technologies
Calibrex Technologies is a contract & development, US-based manufacturer specializing in point-of-care medical devices and consumables.
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