How major medtech companies are responding to the looming EU MDR
Medtech companies that sell products in the European Union have a major deadline looming — one that’s already been put off once…….
EU MDR Approval: Performing the Literature Search
Under the new regulation, medtech manufacturers can no longer defend their claims with limited clinical data; the depth, breadth and scrutiny on clinical data is much more rigorous…….
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How Is Medtech Impacted by a Strained US-China Relationship? A CEO Speaks Out
While some believe cutting ties with China would serve as an impetus for more goods to be made in America, some medtech leaders think it could be disastrous — especially during a pandemic…….
Medtech AI & Software Regulation in China: 5 Things to Know
Regulation in China of AI and software in life sciences is still developing in response to rapid tech advances. Will a shift in regulatory focus in China from point-in-time registration to whole-of-life scrutiny impact AI device approval?……
A Few New Challenges with EU MDR
Experts speaking at MD&M West offered strategies for preparing for the European Union's Medical Device Regulation.
