This agreement includes a number of clarifications to the EU Medical Device Regulations. The Environment, Public Health and Food Safety (ENVI) Committee of the European Parliament and Council’s Committee of Permanent Representatives (COREPER) voted to endorse the trilogue agreement on June 15. The text of the draft MDR is at the link provided. The text...Read More
See the item on the MDR Trilogue Agreement for further explanation. The text for the IVD draft is a the link provided here: EU IVDR.Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.