The European Commissions simplification package is being debated almost entirely as an MDR story. The IVDR provisions carry ...

We’ve all heard the rhetorical question, “Who owns quality?” And we all reply with the answer they expect to hear: “We all do!” This mindset needs to be fully integrated into the minds and systems of ...

Navigate essential biotech and pharma regulations safely. Learn how unifying global standards streamlines audits and ...

Implement AI in quality workflows without regulatory risk. Learn how strong governance and clear validation keep you ...

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The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation 1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — ...

FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections. Early FDA findings ...

AI-assisted symptom recognition and pattern matching leverages machine learning to analyze vast amounts of medical data, including patient histories, clinical notes, and research publications, to ...

Cardiovascular diseases are responsible for over 15 million deaths worldwide per year. 1 The occlusion of vessels such as the coronary or peripheral arteries hinders the flow of blood to the heart, ...

SCS devices deliver electrical pulses to the spinal cord to relieve chronic pain. They are often used as treatment for failed back surgery syndrome, injuries to the spinal cord, complex regional pain ...

An FDA warning letter is more than a formal notice; it’s a visible sign that a company’s quality system has failed to meet critical expectations. Yet behind every warning letter lies a wealth of ...

The majority of IV infusions are performed in acute care settings, such as hospitals and other out-patient centers. 1 Infusion of medication is a common form of treatment in hospitals across the ...