Guest Columns
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A Critical Analysis Of FDA Human Factors IFU Guidance For Drug Delivery Devices
5/8/2024
Drug administration by lay users is becoming more common. Is current FDA guidance viable for demonstrating safe and effective use for critical devices and systems? No.
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AI-Enabled Medical Devices In India: Opportunities And Challenges
5/7/2024
India holds a lot of promise for the medical device sector. But can its regulations catch up with the with growing concerns about AI, security, and bias risks?
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The Global Cardiac Surgery Devices Market: Minimally Invasive Takes the Stage
5/3/2024
New market research reveals a shift away from invasive open-heart surgery toward minimally invasive surgery, driven by transcatheter aortic valve replacements.
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China In The Global Medtech Industry: Equal Parts Promising And Uncertain
5/1/2024
While China is the world’s second biggest market, its activities are mostly focused on its own internal market and a few others. Some new developments are promising, and others raise questions.
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How The Right Operating Model For EU MDR Compliance Can Support A Global Footprint
4/29/2024
EU MDR has raised the bar compared to other jurisdictions in areas such as stronger emphasis on collecting pre- and post-market data. If you align your operating model for EU compliance, you'll be in a better position to enter other markets.
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Integrating Quality Processes And Documentation After A Merger
4/25/2024
If your company is undergoing a merger, you must juggle operations while ensuring minimal disruptions. You'll need a holistic view of QMS and SOPs to harmonize procedures.
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Long Live Design Controls: Navigating The Shift From QSR To QMSR
4/22/2024
The transition to a Quality Management System Regulation (QMSR) has effectively superseded the explicit medical device design controls CFRs and associated FDA guidance, though their essence lives on.
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Sleep Apnea Market Sees Global Shift From CPAP To APAP Devices
4/18/2024
This article shares new market research for the sleep apnea devices market, including overall growth factors and the global shift from CPAP to APAP devices.
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FDA Warns Industry Of Fraudulent & Unreliable Lab Testing Data In Premarket Submissions
4/11/2024
The FDA recently announced that they have seen an increase in the number of entities that contract out testing or services where the data provided by said firms was fabricated, duplicated, or just deemed “unreliable.” Here's what you can do.
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Will Argentina Be The Next Medtech Clinical Trial Destination In Latin America?
4/10/2024
With a population surpassing 44 million, Argentina presents a compelling proposition for medtech clinical trials, bolstered by its robust healthcare system, modern facilities, and experienced medical professionals.