Uniting Precision and Innovation for Medical Device Manufacturing.

A pioneering force in the realm of Laboratory Diagnostic and Point-of-Care Testing Devices

Our Medical Device Manufacturing Process

A CDMO takes your products from innovation through design to validation of your concept. Operating in a fully ISO 13485:2016 facility, we will get you ready for FDA approval.

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:


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:

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 & Software Development

Supporting specific custom research applications to clinical assay support applications, is at the heart of Calibrex.

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.

Our Clients Over the Years

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 companies 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 to healthcare providers.

Ready to turn your medical device concept into reality?