DSM Biomedical offers a variety of different medical-grade Ulteeva Purity® fibers for numerous medical applications, including medical devices in orthopedic trauma, medical implants, and other uses in ...

Supplier quality failures are a leading cause of medical device recalls. This article distills a practical framework for ...

The digital revolution that resulted in the Internet of Things (IoT), Internet of Medical Things (IoMT), Software as a Medical Device (SaMD), and connected devices permeating the healthcare ...

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

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 ...

Product labels that appear on device packages, admittedly, are not the most exciting part of medical device product design and development. They lack the excitement of scientific discovery, the cachet ...

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 ...

This article discusses why Colombia, despite the global effects of the COVID-19 pandemic, has become the country with the best commercial advantages in South America and one of the three best in Latin ...

The regulatory landscape for pharmaceutical and combination products continues to evolve, with increasing efforts toward global harmonization across agencies and standards organizations. While many ...

Periodically, standards are revisited by international and national committees to determine if they are still current or need revision or withdrawal. Through the voting process and based on comments ...

Corrective and preventive actions (CAPAs) are an important and integral part of any quality system for a life sciences company. One would expect CAPAs to be done well. And yet, strangely, CAPAs rank ...

Each clause contains the requirements as well as sub-clauses, which support the main clause by providing the details of the standard’s requirements for a QMS. For the purposes of this article, 21 CFR ...