Manufacturers can benefit from the extended transitional period for legacy devices under certain conditions. One being to have set up a Quality Management System (QMS)…
MDR: Harmonised standards for QMS and risk management
Since May 26, 2021, the medical device sector experienced a great change. The new Regulation replaced the previous Directive and from that date, manufacturers of…
IVDR: Harmonised standards for QMS and risk management
May 26, 2022, is an important date for all stakeholders of the IVD sector. The new Regulation on in vitro diagnostic medical devices (IVDR) will…