FDA Registered, ISO13485 Certified
medical device compliant clinical pilot production
Compliant Clinical Build
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. Our unique service combines engineering-based transfer to manufacturing and procedure-based assembly and test processes ensuring that every device built meets requirements. Compliant Prototype builds are conducted by 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.
Why You Need This
HDA provides contract manufacturing and compliant pilot production to the medical device and IVD industries. But what is Compliant Clinical (or Pilot) Production?
Companies often need small numbers of pre-production or Beta Prototype devices that are fully compliant with all specifications, documentation, quality, and 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 quantity. 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.
Pilot Intake
Disposable Assembly
ISO Certified Quality Management System
Our robust quality system allows us to provide you with world-class products throughout their life cycle. This means better designs, complete documentation and safe, effective and reliable products in the field.
We believe that our commitment to quality is crucial to your success, and continue to invest in our people and quality management system (QMS) to ensure that we deliver the best value to our clients by using well-established development, production and documentation methods.
HDA is certified to ISO 13485 for the design and manufacture of medical devices, and registered with the FDA and California FDB to manufacture medical devices.
ISO13485
Our Quality System is certified to ISO 13485 for the design and manufacture of medical devices.