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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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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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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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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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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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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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AI for Process Optimization: How to Improve Manufacturing Efficiency

Join us for an interactive webcast exploring how artificial intelligence (AI) is transforming manufacturing efficiency. This engaging session will highlight practical applications of AI that enhance ...
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CAPA PROCESS – STEP-BY-STEP INSTRUCTIONS

Corrective And Preventive Action (CAPA) is often discussed as it is an alarming issue for the life sciences industry. Organizations consider its importance and try to deal with it better as CAPA's are ...
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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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FDA Issues Proposal To Amend The Medical Device Quality System Regulation

The FDA is proposing to modify the requirements of its Good Manufacturing Practices (cGMP) regulations to align them with the requirements of the ISO 13485:2016 standard for medical devices. The ...
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Change Control | How to Manage a Change Management Process?

Change management is when an organization creates a step-by-step protocol to manage and implement modifications to products and processes. A change management plan is a protocol that implements and ...
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SOX-IT Controls

The Sarbanes-Oxley Act (SOX) is a U.S. law that was passed in 2002 to protect investors by preventing fraudulent accounting and financial practices at publicly traded companies. The law's purpose is ...