Product Evaluations & Regulatory Submissions (510(k) and AOAC Certification Services)
Let Hardy Diagnostics help bring your product to market!
Hardy Diagnostics is an employee owned company with over 40 years of experience in the microbiology culture media industry. Our technical and regulatory teams consist of microbiologists highly experienced in the introduction of diagnostic products into the US market. Our staff has over 100 years of combined industry experience, as well as extensive knowledge and expertise in clinical trials and experience in navigating the FDA’s clearance process.
Comprehensive Product Assessment
- Microbiology medical devices
- Consulting services – business intelligence
- Feasibility analysis
Analytical Supportive Testing
- Analytical sensitivity and specificity
- Cross reactivity studies
- Limit of detection (LoD)
- Reproducibility
- Other
Regulatory Submissions
- FDA Q-submission
- 510(k) for class II medical devices
Study Design, Planning & Coordination
- Drafting study protocols
- Selection of clinical trial sites
- Coordination of clinical study
- Site training
- Data monitoring and management
- Data analysis
- Microbiology medical devices
Additional Services
- Data analysis
- Technical medical writing
- Susceptibility profile determination of resistant microorganisms
- Vast, well-characterized collection of microorganisms available for product evaluations and new antibiotic candidate assessments
About the Team
Our team is made up of professionals with varying backgrounds and years of experience bringing a new perspective to each 510(k) submission. Our team has been instrumental in having over 25 products cleared by the FDA. Part of this experience includes several successful 510(k)s, mainly in antimicrobial resistance detection devices. Most recently, NG-Test CARBA 5, a CE marked test available and distributed globally by NG Biotech throughout Europe, was FDA cleared by our team.
