The introduction of EU 2017/745 (“EU MDR”) has brought about significant changes within the medical device industry. The fundamental landscape of our...
Important Updates - EUDAMED
In June 2023, the European Commission (“EC”) released its comprehensive user guide for EUDAMED for UDI Devices. EUDAMED is the IT tracking system...
Important FDA Updates - Software as a Medical Device "SaMD"
On June 14, 2023, the FDA published the final version of its software guidance titled “Content of Premarket Submissions for Device Software...
Quality Challenges in Automotive - 5 Things You Need to Know
The automotive industry has certainly had its share of challenges over the past three years. The COVID-19 pandemic, supply chain issues including...
What you need to know about Software as a Medical Device "SaMD"
In recent years, software has become an increasingly prevalent factor in multiple industries, and the medical device community is no exception. The...
New Medical Device Cybersecurity Regulation
On March 29, 2023, Section 3305 of the Consolidated Appropriations Act of 2023, Ensuring Cybersecurity of Medical Devices, (“Section 3305”) became...
EU MDR & IVDR Amendment - Q&A Update
In last month’s blog, we covered the European Council’s (“EC”) amendment which extends the transition deadlines for the certification of medical...