Overcoming the regulatory challenges to achieve global market access
Global regulatory requirements for medical devices differ widely in scope and interpretation. These disparities can delay product launches, elevate compliance…
Congenius
Global regulatory requirements for medical devices differ widely in scope and interpretation. These disparities can delay product launches, elevate compliance…
Congenius
Our MedTech news for April 2026 covers updates on device classification and the expansion of WET devices under the EU…
Congenius
Our MedTech news for February 2026 covers further evolution for global device regulation – with new EU harmonised standards, a…
Congenius
Our April 2025 MedTech news covers new harmonised standards from the EU Commission, updates from MedTech Europe on IVDR, MDR,…
Congenius
Our MedTech news roundup for January 2025 covers the amended IvDO, MedTech Europe’s 2024 Regulatory Survey results, the latest endorsement…
Congenius
Our MedTech news roundup for June 2024 includes the latest on Swissdamed, a fact sheet from MedTech Europe on new…
Congenius
Our MedTech news roundup for May 2024 spans a new combined studies project from the EU Commission, new guidance from…
Congenius
Our April 2024 MedTech news roundup covers an update from Swissmedic on medical device software, guidance from the MDCG regarding…
Congenius