Why Risk-Based Thinking Is Essential in Medical Device Development
Many global regulatory requirements now include risk management, so medtech companies may need to revisit their quality system processes……
Traceability Requirements in EU MDR
Medical device manufacturers marketing products in the EU must ensure traceability between all stages of medical device development and post-market activities…….
The Critical Importance of Patent Protection for Diagnostics in the COVID-19 Era
Court cases have established the means for determining the patent eligibility of diagnostic methods. Does your diagnostic pass the test?……
How does HIPAA affect medical devices?
Medical device manufacturers need to understand patient privacy law and how to comply with it…….
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…….
Building a Better Supply Chain Through Unique Device Identification
Class I medical device companies have work to do, despite the UDI enforcement delay…….
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.
