HDA’s Compliant Clinical Prototype Production service meets your needs for low volume, human-use devices for clinical testing and to support 510(k) filings.
Companies often need small numbers of pre-production or Beta Prototype devices that are fully compliant with all specifications, documentation, quality, traceability and performance requirements. This is particularly important when a device is nearing 510(k) submission. This is Compliant Clinical Production or Compliant Pilot Production.
Not all product design firms are ISO-13485 registered, and most do not have contract manufacturing located alongside their engineering group. This can cause problems when compliant and traceable devices are needed in small quantities. The challenge is finding a contract manufacturer that will take on a low-volume build, develop the necessary additional documentation, assembly, and test procedures, and debug the supply chain and production process. With many products, and particularly with complex ones, there can be significant engineering effort required to resolve problems with documentation, materials, and components, develop assembly methods, and refine test procedures.
In this context, our unique service combines engineering-based transfer to manufacturing and procedure-based assembly and test processes, ensuring that every device built meets requirements.
At HDA Technology, compliant prototype builds are conducted by our experienced engineers, technicians, and support personnel so that you can have complete confidence in every unit built. Every medical product produced by HDA is built to a fully ISO 13485 compliant documented process in our FDA and FDB registered facility.
Development of assembly and test procedures and other Design History File support items are included with this service. All necessary DHF remediation is provided. We will create, correct or complete documentation to ensure that your device can be trusted in clinical use and that you are ready for your FDA filing.
Providing state of the art technical expertise with old-world craftsmanship to medical startup and multinational companies worldwide, HDA is based in Orange County, California. We are proud to partner with you to take your newest ground-breaking innovation from concept to market.
