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Home » Medical Device GMPs » Page 2

Medical Device GMPs

Top cGMP Violations in Analytical Labs FDA 483 and Warning Letter Trends
July 13, 2025
by VelSafe Staff Insights

Top cGMP Violations in Analytical Labs: FDA 483 and Warning Letter Trends

Analytical labs play a central role in drug development and manufacturing. Whether testing raw materials, finished products, or environmental samples, the accuracy and integrity of lab data are vital for patient safety and regulatory compliance. That

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Is ISO 90012015 Legally Required Understanding Its Role in Regulatory Compliance
July 9, 2025
by VelSafe Staff Law

Is ISO 9001:2015 Legally Required? Understanding Its Role in Regulatory Compliance

ISO 9001:2015 is one of the world’s most recognized quality management standards. It helps organizations build reliable systems, improve consistency, and meet customer expectations. But a common question still comes up: Is ISO 9001 legally required?T

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Ensuring QMS Compliance During Holiday Downtime A Guide for Medical Device
July 9, 2025
by VelSafe Staff Situational

Ensuring QMS Compliance During Holiday Downtime: A Guide for Medical Device Teams

The holiday season can be a peaceful break for many, but for medical device companies, it can create challenges for maintaining compliance. With operations slowing, key staff taking time off, and regular routines being disrupted, staying aligned with

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How to Implement a QMS for Medical Devices A Step-by-Step ISO 13485 Guide for Compliance
July 1, 2025
by VelSafe Staff Guides

How to Implement a QMS for Medical Devices: A Step-by-Step ISO 13485 Guide for Compliance

ISO 13485 Medical Device QMS Guide /* Base adjustments that complement inline styles */ :root { --text: #2a2a2a; --muted: #374; --brand: #24667a; } body { color: var(--text); } header p,

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Hazard Communication in FDA Workplaces A Role-Based Overview
June 29, 2025
by VelSafe Staff Worker Safety

Hazard Communication in FDA Workplaces: A Role-Based Overview

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Avoid These Common Mistakes in Process Validation
June 28, 2025
by VelSafe Staff Tips

Avoid These Common Mistakes in Process Validation

/* ---------- Theme Tokens ---------- */ #gmp-sections{ --ink:#0f2e2a; --muted:#2a4e46; --accent:#19c37d; --accent2:#3aa0ff; --ring:rgba(25,195,125,.18); --bg1:#f6fffb; --bg2:#eef7ff; --card:rgba(255,255,255,.86); --shadow:0

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