Recent advances in AI, including machine learning, natural language processing, and deep learning models, are transforming ...

Review the implementation of a holistic Contamination Control Strategy (CCS). Discover four key considerations for assessing ...

It was imperative for a large European CMO that produces multiple biologic drugs to select the right product quality and ...

Gain insight into three areas that have been key in ensuring a robust contamination control strategy to help ensure ...

Managing an electronic trial master file (eTMF) is a complex and labor-intensive effort. Centralize and streamline your clinical activities with MasterControl eTMF software systems. Administering a ...

Article 16 of the European Union’s Medical Device Regulation and In Vitro Diagnostic Regulation specifically address the obligations of importers and distributors who engage in relabeling and ...

In the medical device industry, the stakes of an FDA inspection are high. Non-compliance can lead to delayed market access, product recalls, or regulatory actions that can jeopardize a company’s ...

The rapid evolution of telehealth is transforming how patients access — and physicians provide — care, a shift accelerated by policy changes adopted during the COVID-19 pandemic. The announcement in ...

The updated requirements for post-market surveillance (PMS) under the EU Medical Device Regulation (MDR), EU In Vitro Diagnostics Regulation (IVDR), and the U.K.'s forthcoming Statutory Instrument (SI ...

Auer Precision CO Inc., Mesa. Az, had a firing problem among Auer's super precision products are tooling for ceramic substrates-dies about 8" square, with as many as 2500 holes, some as small as 0.006 ...

A new concept in ampoule packaging, molded entirely of plastic and safe for unlimited consumer use, is available from James Alexander Corporation under the brand name plastiqueAmp A new concept in ...