Where Pioneering Technology Meets Regulatory Expertise
Navigate the LDT to IVD Transition with Trusted Regulatory Expertise
100%
Transition from LDT to IVD
Bridging Clinical Labs and Research with Over 10 Years of Expertise
10+
Years of Expertise as a medical director
Engagement Features
Driving Innovation in LDT to IVD Conversion
Pioneering the Path from LDT to IVD
We specialize in guiding labs through the critical transition from Laboratory Developed Tests (LDTs) to In Vitro Diagnostics (IVDs), ensuring compliance, enhancing quality, and driving innovation every step of the way.
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Equip Labs with Processes for IVD Development
Empowering Labs for Successful IVD Development
Our expertise in IVD development equips labs with the processes and knowledge necessary to create robust, compliant diagnostics that meet regulatory standards and improve patient outcomes.
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Global Leadership in IVD Standardization
Setting the Standard in IVD Globally
As global leaders in IVD standardization, we help labs align with international standards, ensuring consistency, quality, and compliance in diagnostics across borders.
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Ensure Regulatory Excellence in IVD Transition
Achieving Excellence in IVD Regulatory Compliance
Our comprehensive approach ensures labs excel in the regulatory transition from LDT to IVD, providing the support needed to meet stringent compliance requirements and maintain operational excellence.
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Engagement Features
Accelerate Your Innovation
Fast-Track Regulatory Readiness
For startups aiming to make a big impact quickly, we provide tailored solutions that fast-track regulatory readiness. Our expert guidance helps you navigate complex regulatory landscapes, ensuring your innovative products meet all necessary standards and reach the market faster.
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Scalable Growth Strategies
Building a Strong Foundation
We help startups lay a solid foundation for scalable growth. From developing robust quality management systems to ensuring compliance with industry standards, our solutions are designed to support your journey from concept to commercialization.
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Optimize Compliance
Maximize Efficiency and Compliance
For mature ventures looking to optimize their operations, we offer advanced compliance solutions that streamline processes and enhance efficiency. Our expertise ensures your established business remains at the forefront of regulatory compliance, minimizing risks and maximizing productivity.
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Expand Your Market Reach
Fast-Track Regulatory Readiness
For startups aiming to make a big impact quickly, we provide tailored solutions that fast-track regulatory readiness. Our expert guidance helps you navigate complex regulatory landscapes, ensuring your innovative products meet all necessary standards and reach the market faster.
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About Us
Empowering Innovators, Transforming Healthcare
NQ8 specializes in providing regulatory oversight to clinical laboratories transitioning from LDTs to IVDs, offering comprehensive support from initial compliance assessments to full regulatory submission and post-market surveillance. With Dr. Bratton at the helm, NQ8 is uniquely positioned to offer labs the strategic guidance they need to thrive in a rapidly evolving regulatory environment.
NQ8 is committed to bridging clinical labs and research, guiding clients through the complexities of regulatory compliance to drive innovation and ensure excellence.
Year 1: Initial Compliance
Objective: Establish formal processes for MDR as required by 21 CFR Part 803.
Year 2: Intermediate Compliance
Implement a robust system for registration, device listing, and accurate labeling.
Year 3: Advanced Compliance
Develop and integrate quality systems, including design controls and CAPA processes.
Year 4: Continuous Improvement
Conduct regular audits and provide continuous training to ensure long-term compliance.
Setting the Standard in Diagnostic Compliance
By partnering with us, labs gain a strategic ally committed to accelerating their success in a rapidly evolving regulatory environment.
Pioneering Virtual Innovation in LDT to IVD Conversion
At NQ8, we bridge the gap between innovation and regulation. Our virtual platforms are designed to streamline the transition from LDTs to IVDs, providing comprehensive support that includes
- Custom Digital Tools: Tailored solutions for process management, validation, and compliance.
- Regulatory Expertise: In-depth knowledge of the latest regulations to ensure your diagnostics meet all necessary standards.
- Seamless Integration: Helping you adopt and implement new diagnostic methods efficiently and effectively.
With NQ8, you can confidently navigate the complex regulatory landscape, transforming your laboratory innovations into market-
ready IVDs.
Conduct Gap and Feasibility Analysis
Begin your journey by assessing the current capabilities of your lab against industry standards to identify gaps and evaluate the feasibility of transitioning from LDTs to IVDs.
- Perform a comprehensive gap analysis to understand your lab’s strengths and areas for improvement.
- Identify regulatory requirements specific to your diagnostic product.
- Determine the resources and timelines needed for successful clinical validation and utility studies.
Develop an Integrated Clinical Validation and Regulatory Strategy
Create a roadmap that aligns your clinical validation goals with regulatory compliance, leveraging partnerships with regulatory and quality experts.
- Collaborate with regulatory and quality management experts to develop a validation plan that meets FDA and global standards.
- Identify critical milestones, resource requirements, and timelines for your validation and regulatory journey.
- Engage with liaisons who specialize in clinical research, regulatory affairs, and quality management to ensure a seamless integration of clinical validation with regulatory requirements.
Design and Implement the Clinical Utility Study
Execute a clinical utility study designed to demonstrate the real-world value of your diagnostic product, using a structured and compliant approach.
- Work with your liaisons to design a study that meets your product’s specific needs, focusing on endpoints, patient selection, and data collection methodologies.
- Implement the study plan, coordinating with your liaisons and data management teams to ensure adherence to all protocols and regulatory guidelines.
- Use advanced data management tools to collect, analyze, and manage study data efficiently. Regularly review interim data to optimize study outcomes.
Ensure Quality Assurance and Regulatory Compliance
Maintain the highest standards of quality and regulatory compliance throughout the clinical validation and utility study process.
- Collaborate with quality management specialists to establish and maintain a robust Quality Management System (QMS).
- Conduct regular audits with quality assurance experts to ensure continuous compliance with all regulatory requirements.
- Prepare comprehensive documentation for regulatory submission, ensuring all clinical data meets the necessary standards for approval.
- Perform a final quality and regulatory compliance review before submission to ensure accuracy and completeness.
Obtain Regulatory Submission and Post-Market Support
Successfully submit your clinical validation and utility study data to regulatory bodies, and continue to ensure compliance and quality in post-market activities.
- Serve as a liaison between your lab and regulatory authorities, ensuring smooth communication and efficient handling of all submissions.
- Submit your clinical study results, validation data, and all necessary documentation to the appropriate regulatory bodies.
- Continue to work with quality and regulatory partners to ensure ongoing compliance with post-market surveillance and quality system updates.