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PANDEMIC HEALTHCARE SOLUTIONS

Pandemic Healthcare Solutions is a clinical and corporate consultancy that specialises in vitro diagnostic medical device (IVD) approval and compliance

We work with our clients on a variety of solutions, including:

  • Securing TGA approval for new devices and processes through clinical trials and performance evaluations

  • Liaising with the TGA on behalf of your business to maintain device approval

  • Developing clinical and corporate governance documentation tailored to your business

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CLINICAL STUDIES

CARESTART RAPID ANTIGEN TEST USABILITY STUDY

DNANUDGE COVIDNUDGE USABILITY STUDY

CARESTART RAPID ANTIGEN TEST CLINICAL PERFORMANCE EVALUATION (OMICRON VARIANT)

CARESTART RAPID ANTIGEN TEST LIMIT OF DETECTION STUDY

CARESTART RAPID ANTIGEN TEST ACCELERATED SHELF LIFE STUDY

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