July 27, 2022December 22, 2022 stevensevert2 FDA Releases New Draft Guidance for Remote Regulatory Assessments
July 21, 2022December 22, 2022 stevensevert2 Recognition of EN ISO 14971 as a harmonized standard in support of the European Medical Device Regulations
March 2, 2022December 22, 2022 stevensevert2 The FDA Poses ‘Seven Questions’ to Begin Clarifying Details of the QSR Harmonization with ISO 13485
February 23, 2022December 22, 2022 stevensevert2 After Years of Delays, FDA Finally Issues Proposed Rule to Harmonize QSR to ISO 13485
