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The Medpoint Blog
Learn best practices and gain new insights on quality assurance, regulatory strategy, and clinical affairs.
Beyond the Metals Tariffs: Hidden Costs in Medical Devices
July2025
On June 4, 2025, the United States raised the global tariff on aluminum and steel from 25% to 50%, w...
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In January 2025, the FDA released a draft guidance titled Obesity and Overweight: Developing Drugs a...
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Understanding the ISO 9001 Climate Change Amendment: What it Means for Certified Organizations
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The role of ISO 9001 in quality management is to provide a standardized framework for Quality Manage...
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The Underappreciated Science of Soft Skills in Medical Device Audits: Insights from Andy Nichols
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Medical device audits are vital for ensuring compliance, maintaining quality, and safeguarding patie...
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Post-Pandemic Lessons on Supply Chain Vulnerabilities
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The COVID-19 pandemic exposed significant vulnerabilities in global supply chains, challenging long-...
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FDA’s New Draft Guidance on Clinical Trial Diversity: What Sponsors Need to Know
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Cutting Costs or Cutting Corners? The True Cost of Skipping Supplier Audits.
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QMSR: Harmonizing 21CFR820 & ISO 13485 – What is the impact on industry?
August2024
The medical device industry operates under a complex web of regulations, with 21 CFR Part 820, commo...
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How Does Quality Culture Contribute to Compliance?
August2024
Creating a quality culture within the workplace is foundational to quality compliance. The keystones...
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