The agency's Center for Devices and Radiological Health has formally recognized pyrometry standard AMS 2750 for heat treating. Originally drafted by SAE International in 1980 for the aerospace industry, the standard is the foundation of heat treating audit criteria for the burgeoning medical device supply-chain oversight program MedAccred.
A pyrometry standard originally developed for the aerospace industry has been formally recognized by US FDA's Center for Devices and Radiological Health.
Drafted by SAE International in 1980 – and revised four times since – AMS 2750 covers pyrometric requirements...
EU countermeasures against US tariffs suggest medtech categories exported to the EU could be targeted for tariffs. MedTech Europe and the German IVDs industry have stressed the negative effects this would have on patient care.
Innovative Healthcare is asking for a permanent injunction against Johnson & Johnson subsidiary Biosense Webster after winning a $442 million antitrust verdict. The injunction aims to prevent continued anticompetitive practices in the electrophysiology catheter market.
16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.
