I3CGLOBAL MDR CE MARKING, Resources April 11, 2022 How to CE Mark your Medical Devices and Avoid Problems! * In general, clinical studies will not be needed for most surgical suture devices, FDA may recommen... Read More
I3CGLOBAL FDA 510k January 22, 2022 Surgical Sutures 510(k) * In general, clinical studies will not be needed for most surgical suture devices, FDA may recommen... Read More
I3CGLOBAL MDR CE MARKING October 3, 2021 Person Responsible for Regulatory Compliance, (PRRC) The person responsible for regulatory compliance (PRRC) is not intended to take the place of a Europ... Read More
ShareThoughts MDR CE MARKING, Medical Device, Resources February 14, 2021 Custom-made Medical Devices ... Read More
QARA MDR CE MARKING February 12, 2021 Sampling Plan The sampling criteria: The main sampling criteria are lot sizes, inspection levels, acceptable qua... Read More
ShareThoughts MDR CE MARKING, Medical Device, Resources February 11, 2021 Medical Device Common Terms Definitions Common Terms Used and their definitions are following Medical Device Medical device’ means any ins... Read More