The introduction of EU 2017/745 (“EU MDR”) has brought about significant changes within the medical device industry. The fundamental landscape of our...
In June 2023, the European Commission (“EC”) released its comprehensive user guide for EUDAMED for UDI Devices. EUDAMED is the IT tracking system...
On June 14, 2023, the FDA published the final version of its software guidance titled “Content of Premarket Submissions for Device Software...
The automotive industry has certainly had its share of challenges over the past three years. The COVID-19 pandemic, supply chain issues including...
In recent years, software has become an increasingly prevalent factor in multiple industries, and the medical device community is no exception. The...
On March 29, 2023, Section 3305 of the Consolidated Appropriations Act of 2023, Ensuring Cybersecurity of Medical Devices, (“Section 3305”) became...
In last month’s blog, we covered the European Council’s (“EC”) amendment which extends the transition deadlines for the certification of medical...
