Higgins McNamara Consulting, LLC

Scientific & Regulatory Advising for IVD Companies

How can I help move your IVD from idea to implementation?

From Idea to Pathway

Have the science but not the regulatory roadmap? I’ll help you chart the way!

Regulatory Strategy & Pathways

Navigating FDA requirements from initial design through approval and commercialization

FDA Submission Support

From “blank page” to FDA-ready Q-submissions, 510(k), PMA, De Novo, and more…

Clinical Operations Readiness

Protocol drafting, IRB approval handling, and coordination of staff training will position your studies for compliance.

Quality & Compliance

With help to align your processes with FDA, ISO, and CAP/CLIA standards, compliance can give you new control rather than being a burden.

Documentation & Records

Lean on my years of drafting SOPs, work instructions, and recordkeeping processes to establish clear, effective workflows for your team!

Don't see what you need? Let’s talk! I can often connect you with trusted colleagues in my network.

Contact me at higginsmcnamaraconsulting@gmail.com

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My Resources page pulls together key references to help you get started and to support our work together; these are the same tools I draw on when working with clients to turn standards and regulations into practical steps.

HMC Founder: Christina "Tina" Higgins, Ph.D., RAC-Devices

Tina is an IVD regulatory consultant who provides scientific and regulatory advising to companies developing in vitro diagnostics for market or implementing them in broader clinical and research settings. Her scientific training and industry experience are valuable assets to companies navigating FDA-compliant design and development. Clients rely on her to bridge science with regulatory expectations and to deliver practical, responsive guidance that keeps projects moving while maintaining rigor.

During her career, Tina has supported the development of numerous IVDs across oncology, infectious disease, hematology, inflammatory processes, and inborn errors of metabolism. Platforms have spanned point-of-care devices, high throughput instruments, and configurations suitable for Laboratory Developed Tests. She contributed to the development and approval of OPKO Diagnostics’ multi-analyte algorithmic 4Kscore Test and has guided other products through key stages of validation and submission. As a former executive in multiple organizations supporting IVD validation and regulatory strategy, she is experienced in coordinating across companies and functions to achieve success.

Tina earned her Ph.D. in Biomedical Sciences from Cornell University (Weill Graduate School of Medical Sciences) and her B.S. in Biochemistry from Worcester Polytechnic Institute. Tina holds the Regulatory Affairs Certification (Devices) and is an active member of both the Regulatory Affairs Professionals Society (RAPS) and the Association for Diagnostics & Laboratory Medicine (ADLM). She has contributed to standards development as a longstanding committee member with CLSI. Based in the Phoenix area, she consults on both long- and short-term projects.

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