Regulatory & Compliance Perspectives
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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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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The transition to a Quality Management System Regulation (QMSR) has effectively superseded the explicit medical device design controls CFRs and associated FDA guidance, though their essence lives on.
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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.
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Understanding The New MHRA Requirements For Medical Devices In Great Britain
4/9/2024
The U.K.’s MHRA has updated its transition arrangement dates for CE marked devices with regard to EU MDR compliance.