Higgins McNamara Consulting | Take your IVD from idea to implementation! | • Advisor to medical device companies and research groups nationwide on regulatory strategy, quality system implementation, government funding applications (BARDA, NIH, SBIR, etc.), and experimental design supporting IVD validation (including transition of LDTs to cleared/approved devices) and other research efforts • Develop and prepare a wide variety of regulatory and technical documentation, including experimental, analytical, and clinical protocols/reports, manufacturing documentation, regulatory submissions, grant applications, and lecture/educational materials; supporting literature review and scientific design included • Provide project coordination, training support, and advise on regulatory budget planning and resource allocation