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How to get your COVID-19 Related Medical Device to Market Under FDA Emergency Use Authorization (EUA)

A session by Kyle Rose
President, Rook Quality Systems

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About this talk

What quality and regulatory steps are needed to get your COVID-19 related device on the market under FDA Emergency Use Authorization. The FDA has been very active in publishing new guidances and updates for COVID-19 related devices that are in high demand. RookQS has worked with many manufacturers and distributors around the world to address the COVID-19 related shortages on devices, diagnostics, and PPE.

• Overview of the requirements for the COVID related devices and supplies under high demand during the current COVID pandemic

• Overview on diagnostic and at home testing kits

• Overview on hand sanitizer registration and testing for manufacturers and distributors

• Overview on respirator regulations and testing for manufacturers and distributors

ABOUT ROOK QUALITY SYSTEMS:

Rook QS is composed of medical device quality experts with experience in a wide range of medical devices and technologies. We work closely and efficiently with our clients to meet their quality needs and ensure their products meet and exceed regulations and standards. PRE-MARKET - Our scope of work covers initial quality system design through completion of design history files and risk management files. POST-MARKET - We provide a variety of QMS related services depending on the client and size of the company. We often support DHF remediation projects for hardware and software devices to help achieve market clearance. Our consultants can complete remediation projects in less than one month in certain situations. Rook QS has worked on multiple SaMD products with great success and is a leader in the medical device software community.