Our customers work in clinical, research, food, water, and pharmaceutical testing laboratories and we understand their needs. Hardy Diagnostics is an FDA licensed in vitro medical device manufacturer and operates under an ISO 13485 certified Quality Management System. Our reputation and expertise in the industry and our commitment to our customers ensures superior service, and high quality, dependable products at competitive prices.
Hardy Diagnostics has vast experience in creating new variations of existing products or the development of new products and proprietary formulations. For proprietary formulations, we offer nondisclosure agreements (NDA) to ensure confidentiality. Hardy Diagnostics offers manufacturing process validation, failure mode analysis, bioburden testing, sterility testing, and testing services using the latest industry tools and standards to perform in-house validations by a team of highly trained, cross-functional Quality Assurance Engineers and microbiologists.
Hardy Diagnostics also offers private labeling of custom designs, co-development of new technologies, or large scale contract manufacturing projects. Hardy Diagnostics also offers real-time product stability testing. In conjunction with our extensive organism library, we can perform challenge growth promotion testing to match the intended use of custom products. Our staff has over 50 years of combined industry experience, as well as extensive knowledge and expertise in clinical trials and experience in navigating the FDA’s clearance process.
For more information check out our website: https://hardydiagnostics.com/services/