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 ...

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 ...

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, ...

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, ...

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 ...

"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 ...

Computer Software Assurance (CSA) is a new methodology that takes a risk-based approach to validation activities. It was driven by the FDA and life sciences industry to streamline verification and ...

Envision a not-so-distant future, when logging into your computer opens the door to an instantaneous digital replica of your company's manufacturing line. In this virtual world, a constant stream of ...

ISO 14971 – Medical Device Company’s risk management standard. Although there are only a few medical device safety measures to consider, ISO 14971 is a widely accepted standard for risk management in ...

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 ...

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 ...

As the English saying goes, "Potato, Potato" doesn't translate well in the written form. Still, it's saying the same vegetable but with a different pronunciation, meaning it doesn't matter how you say ...