Guest Columns
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PMS And Supply Chain Visibility For EU Compliance
2/10/2025
One area that medical device manufacturers often overlook in post-market surveillance (PMS) planning for EU MDR and EU IVDR compliance is the role of the supply chain.
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Comparison Of Sterilization Methods: Vaporized Vs. Aerosolized Hydrogen Peroxide
2/5/2025
Hydrogen peroxide (H2O2) is one of the most frequently used chemical compounds for sterilization. This article compares the benefits and trade-offs of using the vapor form vs. aerosol form.
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A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices
2/3/2025
Human errors account for many manufacturing failures, simply due to the roles in our activities and systems. Relational risk analysis (ReRA) fundamentally changes the way risks are analyzed.
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These Were FDA's Top Citation Issues For Data Quality In 2024
1/31/2025
Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate procedural controls and poor record-keeping.
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Enhancing Trust, Safety, And Performance Through Explainability In AI-Enabled Medical Devices
1/27/2025
Many AI-enabled medtech products leverage machine learning or deep learning. In order to address the opaque decision-making processes, explainability is essential to enhance trust, safety, and performance.
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Computer Systems Validation Pitfalls, Part 4: Inattention To Details
1/24/2025
The authors conclude their 4-part article series on computer systems validation (CSV) pitfalls using real case studies to illustrate points related to inattention to details.
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Make It A No-Brainer: Designing For Electronic Medical Device Usability
1/14/2025
When designing and developing electronic medical devices for users who may be in pain, under duress, or untrained, the goal is clear: make it simple.
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Only DTx In Drug Delivery Can Take Us To The Next Level Of Diabetes Care
1/8/2025
The convergence of advanced technologies and advancements in drug delivery is reshaping diabetes care. Digital therapeutics (DTx) deliver therapeutic interventions driven by high-quality software and mobile applications.
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11 Key Contributing Factors For Maintaining Sterility Assurance
1/6/2025
Containers and closures, depyrogenation, equipment, materials, personnel, and 7 more major factors all contribute to sterility assurance.
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U.S. Deregulation During The Trump Administration: Opportunities And Challenges For The Global Medical Device Industry
1/3/2025
The medical device sector faces significant changes, as both Donald Trump and Robert F. Kennedy Jr. have identified the FDA as a focal point for deregulation. What does this mean for medical device companies?