“Voice of Patient” in Publications: Trends and Perspectives
PLS play an important role in increasing the accessibility of medical publications to a wide audience. We assessed readability of PLS in published literature vs that of PLS developed using generative AI (genAI)...
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Medical Affairs 2.0: GenAI as the Catalyst for
Digital and AI were hot topics underpinning many of the...
Biopharma Trends 2025: 3 Things to Know Right Now
The global business climate is ever-evolving, and 2025 looks...
The Paradigm Shift from Traditional Scientific
In the rapidly evolving biopharma landscape, the approach to...
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The Paradigm Shift from Traditional Scientific Platforms to Integrated Communications Plans
In the rapidly evolving biopharma landscape, the approach to scientific communications is undergoing a significant...
Periodic Safety Update Report (PSUR): A Breakdown of MDCG 2022-21
A well-structured, clear, and concise PSUR enables a seamless notified body review. Read our key...
Clinical Evidence: How Much Is Enough?
Ensuring the safety and functionality of your medical device is vital. But how much clinical...
Which Regulatory Requirements Are Applicable to “Legacy” Devices?
Understanding the requirements for your medical device is vital in today’s market. But are these...
Simple Considerations before Determining S&P Objectives for Medical Devices
With all the things to consider with Medical Device Regulations, it's important to identify the...
Medical Device Manufacturing: Risk-Based QMS Alignment for EU MDR
The latest EU-MDR guidelines are a step in the right direction, moving from a focus...