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In this post, we pull out key takeaways from a recent whitepaper written in conjunction with Beanstock Ventures on the new EU medical device regulations (EU MDR) and how they might impact medical device development. As medical device technologies have rapidly advanced in recent years, regulations governing definitions, testing, and post-market activities have struggled to […]
The medical device market in Europe is growing fast and is expected to reach $61.4 billion by 2025, up from $48.9 billion in 2020. A large aging population, demand for more surgical procedures, and technological expansion are driving this trend. The Medical Device Directive (MDD) is a legal framework that includes three directives that are […]
Editor’s Note: This posts on EU MDR was originally published here by MedTech Drive and written by Greg Slabodkin. Dive Brief: While the Medical Device Regulation’s May 26 go-live date marks a significant milestone, MedTech Europe warned in a statement that MDR challenges remain, limiting the industry’s ability to “seamlessly supply certified devices under the new rules.” The European trade […]
In this post, subject matter experts from Jama Software and Beanstock Ventures discuss predictions for medical device product and systems development in 2021 and how they might impact the way your team works.
Medical device manufacturers have a lot to keep track of these days. Between ongoing device development and preparing for the impending EU MDR, it’s more important than ever to maximize every partnership.
EU MDR which emphasizes patient safety, traceability, and transparency, will impact medical device developers, manufacturers, and suppliers across Europe.
3 improvement strategies to insert risk control as a crucial part of the medical device development framework to comply with ISO standards and EU MDR.