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.
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
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.