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CSA in the Era of QMSR: How FDA’s New Regulation Redefines Assurance Expectations

As FDA’s Quality Management System Regulation (QMSR) takes effect on February 2, 2026, medical device organizations face the most significant shift in quality and compliance expectations in decades.
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ISPE-CaSA 33rd Annual Technology Life Sciences Show

Compliance Group is excited to exhibit at the ISPE-CaSA 33rd Annual Technology Life Sciences Show, one of the region’s premier Life sciences events, taking place on February 25, 2026, in Raleigh, ...
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Process Validation | US FDA Medical Device Validation Process | Why it’s Important?

The US Food and Drug Administration (FDA) is responsible for protecting public health by ensuring medical devices' safety, efficacy, and quality. The agency has developed a rigorous medical device ...
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Medical Device Recall: How does US FDA recall Medical Device work?

Medical devices, unlike prescription drugs, are reviewed by the United States (US) Food and Drug Administration (FDA) under one of two regulatory standards - Premarket approval (PMA), which requires ...
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Validation of packaging and sterilization – What Manufacturers get wrong?

Packaging and sterilization validations are a critical step in the development and manufacturing of medical devices, as they ensure patient safety, regulatory compliance, product quality, and the ...
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Risk Management – How to document a Risk Management Plan (RMP)?

The development of new medical devices or any new project brings a new set of risks. A Risk Management Plan (RMP) must be developed at the start of the Risk Management Process for a new project or ...
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FDA EUA | FDA Emergency use Authorization for Medical Devices

"In case of an emergency, please dial 911." That's one kind of emergency, but not what we'll address today. This emergency is in light of COVID-19. Simply, it's the power of the FDA to grant Emergency ...
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Guide on How to Pass the FDA’s 5 Stage Goals to Launch Medical Devices to Market

Bringing medical devices to market is a highly complex, challenging, and regulated process. Medical device manufacturers bear the responsibility of ensuring the safety and effectiveness of their ...
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ISO 9001 Document Control Checklist

Organizations must develop a written method to approve papers for sufficiency prior to issuance. Documents should be reviewed, updated as needed, and re-approved. Determine the changes and the current ...
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E-learning Trends to Watch in 2025

Innovations and Emerging Technologies in the Regulated Environment of Pharma Effective training programs are essential for maintaining compliance, improving operational efficiency, and ensuring data ...
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Document Change Control | Why is DCC a must-have process in life science industries?

In the life sciences industries, documentation plays a crucial role in proving the product's effectiveness and safety. Furthermore, it discusses the processes and practice's dependability, ...
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IEC 62304 | How to Overcome the Challenges in Medical Device Manufacturing?

A functional safety standard called IEC 62304 addresses the secure development and upkeep of medical device software. It offers procedures, activities, and tasks to assure safety. From the outset ...