The most pressing need in the times of COVID-19 is making the Personal Protective Equipment (PPE) like N95 respirator available for healthcare workers. But, as you may know, the rapid spread of the pandemic in the U.S., and the shortage of such equipment has triggered more challenging scenarios. Addressing to the demanding times, one of our clients – manufacturer of novel technology based medical devices, set out to take their filtering face masks to the U.S. market.
Given the unprecedented times of COVID-19 and FDAs numerous guidance documents and Emergency Use Authorizations (EUAs), the manufacturer required Regulatory support to enter the U.S. market without any compliance hurdles.
Come what may, clients’ business continuity is paramount to Freyr. Glad to share that with all proactive measures quickly taken in this scenario, Freyr has made the client enter the U.S. market with successful NIOSH certification.
Would you like to know how? Download this case study.