Medical Device and Technology Regulatory

Representative experience

Assisting multiple clients regarding EUA submissions for COVID-19 diagnostic tests, treatments, and surgical masks.

Advising numerous non-traditional life sciences and device companies on the requirements and logistics of producing critical need supplies.

Advised Vayu Global Health Innovations in obtaining an EUA from FDA that allowed its bubble CPAP device to be immediately distributed to hospitals to help alleviate the ventilator shortage due to COVID-19.

Teamed up with regulatory consultant Wanda Henry Co. to advise Sansure Biotech, Inc. in its FDA EUA for a molecular diagnostic test kit for COVID-19.

Advising Ford Motor Company in its collaboration with GE Healthcare to help reinforce the Strategic National Stockpile and to support the treatment of coronavirus patients.

Advised the Kraft Group/New England Patriots to obtain the necessary government approvals to pick up 1.3 million N95 masks from Shenzhen, China, and deliver them to the Commonwealth of Massachusetts.

Developed an innovative strategy for interacting with FDA for Viz.ai to gain a quick De Novo clearance for a novel Computer-Aided Triage and Notification Platform to identify LVO strokes in CTA imaging.

Successfully assisted IDx LLC to achieve De Novo reclassification from the FDA for the ground-breaking AI-based device IDx-DR, which autonomously analyzes images of the retina for signs of diabetic retinopathy.

Assisted a client in developing a recall strategy that involved all products produced by the company, which was classified as a Class I recall.

Help develop clinical and regulatory strategies for a number of clients that are developing biomarkers and molecular diagnostics that would be companion assays to drugs.

Conducted numerous Quality System Regulation (QSR and ISO 1345) audits domestically and internationally to help companies make their processes more robust and to prepare them for inspections and audits.

Advocated the FDA’s reclassification of a novel imaging device, tissue culture media products for ex vivo growth of human cells, and a variety of in vitro diagnostic test systems, avoiding the need for a PMA approval.

Assisted CSD Labs in obtaining 510(k) clearance of eMurmur, an innovative, AI-based murmur detection software.

Conducted internal investigations and compliance audits to ensure that promotional activities did not violate the Federal Food, Drug, and Cosmetic Act.

Assisted clients with novel devices featuring AI and machine learning algorithms in developing and gaining FDA alignment on creative regulatory strategies to bring these products to market quickly and efficiently.

Worked on pre-market submissions for IVDs in the medical device and biologics areas and on IND applications for imaging agents.

Assisting several medical devices clients in preparing distribution, importer, and authorized representative agreements reflecting the obligations of the EU MDR.