Guest Columns
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3 Lessons Learned From EU MDR Implementation To Ensure IVDR Adoption
5/13/2024
For in vitro diagnostic manufacturers entering the EU market, the key lessons to leverage from EU MDR implementation include early QMS preparation and two other key lessons.
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Stop Inspecting For Quality — Start Building It.
5/10/2024
QC/QA activities that occur too late in the process or rely on a siloed team of inspectors can lead to significant waste and costs. Here’s the approach you should be using.
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4 Critical Focus Areas For Medtech Compliance Leaders
5/9/2024
These four approaches are important for you as compliance leaders at medical device/medtech companies to create impact within your organization.
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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.