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 ...

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

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

Artificial intelligence (AI) and machine learning (ML) are redefining healthcare, from enabling earlier diagnoses and personalized treatments to streamlining hospital operations and accelerating ...

In 2023, the FDA made the electronic Submission Template And Resource (eSTAR) mandatory for most 510(k) submissions. Although eSTAR is not an AI tool, the move was the first definitive leap toward the ...

Since the introduction of the EU MDR in 2017, the medical device industry has learned just how challenging obtaining initial MDR certification truly is. According to a survey of notified bodies, the ...

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 — ...

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 ...

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 ...

Auto-injectors are devices designed to simplify the process of administering injectable pharmaceuticals at home. They are particularly useful for individuals who need to self-administer medication on ...

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 ...