We know how to do it right the first time, including the right level of detail and effort based on your business goals and the risk of your particular tests or devices.
–Chad Gibson, Managing Partner
In Vitro Diagnostics (IVDs) are regulated medical devices used for testing specimens from the human body. Whether you’re implementing quality management best practices for laboratory tests used internally, or preparing to commercialize a diagnostic test for broader distribution, navigating FDA requirements requires specialized expertise. With decades of medical device experience, CMD MedTech is an IVD regulatory consultant helping organizations develop practical, right-sized solutions for quality management and development.
Why Choose CMD MedTech for IVD and CDx Regulatory Consulting
- Extensive experience helping medical device companies develop processes and documentation required for FDA approval of diagnostic tests
- Ability to implement quality systems efficiently with minimal impact on laboratory operations
- Deep understanding of both FDA requirements and hospital laboratory operations
- Experience coordinating compliance across multiple laboratory facilities (e.g., at the hospital system level)
- Expertise in managing the documentation and validation requirements in accordance with 21 CFR Part 11
- We offer our 21 CFR Part 11-compliant electronic document tool for maintaining electronic records and electronic signature compliance
- Our quality systems and documentation practices represent industry best practices that improve operations, enhance patient safety, and reduce liability
When You Need IVD Regulatory Consulting Services
Implementing Quality Management Best Practices for Internal Laboratory Tests
Even when not required by regulation, quality management practices provide significant value for laboratory operations. Good documentation practices, structured test validation, and systematic change management contribute to better patient safety, reduced liability, and operational efficiency. As testing becomes more complex, having these systems in place helps ensure consistent, reliable results and positions your laboratory as a quality leader.
Commercializing Your Laboratory Test
Many hospitals and laboratories develop innovative diagnostic tests for their own internal use. When you want to commercialize these tests and make them available to other facilities, they become regulated IVDs and must go through the FDA clearance or approval process. This transition requires comprehensive quality management systems, design controls, validation documentation, and regulatory submissions. CMD MedTech guides organizations through this entire pathway—from initial assessment through FDA approval and post-market surveillance.
Expanding Your IVD Product Portfolio
If you’re an established medical device company looking to add new diagnostic tests to your portfolio, we help you navigate the FDA diagnostic test approval process efficiently while maintaining compliance with existing quality systems.
How We Price Our IVD Regulatory Consulting Services
We understand that every laboratory and hospital system has unique needs and organizational structures. Our pricing is customized based on your specific requirements, whether you need support for a single laboratory or a multi-lab hospital system. We offer both time-and-materials and fixed-price engagements, allowing flexibility to match your project scope and budget. Contact us to discuss your laboratory’s specific needs and receive a detailed pricing proposal.
5-Step Process for Getting Started With IVD and CDx Quality Management Systems
5-Step Process for Success With IVD Regulatory Consulting Support
Additional IVD Regulatory Consulting Services We Provide
Virtual Quality Support Services
We help with training, document completion, and quality system facilitation to maintain ongoing CDx and IVD quality management and regulatory compliance.
Quality System Maintenance
We provide support for management reviews, internal audits, and continuous system improvement.
Staff Training and Development
We help laboratory staff understand and implement regulatory requirements and quality best practices efficiently.
Electronic Document Management
Through our Astro platform, we provide FDA 21 CFR Part 11-compliant electronic records and electronic signature systems.
New Test Development Support
We assist with FDA submissions and documentation requirements when introducing new tests, whether for internal use or commercialization.
IVD and CDx Commercialization Consulting
We guide laboratories through the complete FDA diagnostic test approval process when transitioning internal tests to market-ready IVDs, including regulatory strategy, design controls, validation planning, and FDA submission preparation.
FREQUENTLY ASKED QUESTIONS
The FDA diagnostic test approval process varies based on your test’s classification and intended use. It typically involves determining the appropriate regulatory pathway (510(k), PMA, or De Novo), establishing design controls and quality systems, conducting analytical and clinical validation studies, preparing comprehensive regulatory submissions, and responding to FDA questions. The timeline can range from several months to over a year depending on complexity. We help you understand which pathway applies to your test and guide you through each step efficiently.
Quality management practices provide value regardless of regulatory requirements. Good documentation practices, structured test validation, and systematic change management contribute to better patient safety, reduced liability, and operational efficiency. As testing becomes more complex, these systems help ensure consistent, reliable results. Additionally, if you ever want to commercialize your tests, having these practices in place positions you for a smoother transition to full IVD regulation and FDA clearance or approval.
When you move from internal use to commercialization, your test becomes a regulated IVD and must obtain FDA clearance or approval. This involves implementing comprehensive quality management systems, establishing design controls, conducting validation studies, preparing regulatory submissions, and obtaining FDA clearance or approval. As a CDx and IVD regulatory consultant, we help you navigate this entire pathway—from initial assessment and gap analysis through FDA submission and post-market surveillance.
We work with hospital administration to determine the most effective way to implement quality management across one or multiple labs. Our team helps establish reporting structures and coordinates between different departments to ensure consistent implementation that works within your existing operations. Whether you’re implementing best practices for internal use or preparing for commercialization, we right-size our approach to match your organizational needs.
Yes, quality management practices for laboratory testing are increasingly recognized as industry best practices, regardless of regulatory requirements. Organizations that implement these practices demonstrate their commitment to quality, patient safety, and operational excellence. This positions them favorably whether they’re operating internally or preparing for commercialization of their diagnostic tests.
We provide scalable IVD and CDx regulatory consulting solutions tailored to your goals. Whether you’re implementing best practices for internal operations, preparing for potential commercialization, or actively pursuing FDA approval for a diagnostic test, we can right-size our support to match your needs and objectives. Our experience spans both laboratory operations and full medical device regulation, allowing us to guide you at any stage of your journey from internal test development to commercial IVD.