IMDRF draft document – Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews
Posts published in August 2019
Unique Device Identification (UDI) System – FAQs
Medical device patient information leaflets and implant cards
EU MDR/IVDR: US Raises ‘Serious Concerns,’ Urges 3-Year Implementation Delay
Medical Device User Fee Rates for Fiscal Year 2020
Updated FDA Resources for Third Party Review Organizations
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment