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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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                            Unlocking the Power of Collaboration – The Key to Inspection Readiness

                            May2025

                            In the highly regulated world of the pharmaceutical and medical device industries, a buzzword that h...

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                            FDA Releases New Guidance on Weight-Reduction Medications: A Comprehensive Overview

                            April2025

                            In January 2025, the FDA released a draft guidance titled Obesity and Overweight: Developing Drugs a...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

                            March2025

                            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

                            January2025

                            Medical device audits are vital for ensuring compliance, maintaining quality, and safeguarding patie...

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                            Post-Pandemic Lessons on Supply Chain Vulnerabilities

                            January2025

                            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                            FDA’s New Draft Guidance on Clinical Trial Diversity: What Sponsors Need to Know

                            November2024

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                            Cutting Costs or Cutting Corners? The True Cost of Skipping Supplier Audits.

                            October2024

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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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                            Beyond the Metals Tariffs: Hidden Costs in Medical Devices

                            Unlocking the Power of Collaboration – The Key to Inspection Readiness

                            FDA Releases New Guidance on Weight-Reduction Medications: A Comprehensive Overview

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