Mitigating risk of failure is one of the most important disciplines to perform for medical device manufacturers, and for the last couple of years, it has become an increasingly difficult discipline to master.
Digital transformation requires a clear vision, buy-in at every level, and significant investment. Here are three steps to streamline the process.
Revised EU GMP Annex 1 requirements must be fulfilled by August 2023. Designed to protect and increase confidence in the sterility of these products, the new specifications are significant and wide-ranging, spanning the Quality system and the manufacturing process itself. Anna Cluet of Rephine discusses the practical specifics of designing and delivering a fit-for-purpose contamination control strategy.
While the terms rapid prototyping, additive manufacturing, and 3-D printing are used interchangeably these days, biofabrication is setting itself apart.
The agency will bring together major stakeholders to discuss challenges in medical device cybersecurity.
Cybersecurity considerations must be part of the design and implementation process.
Ultra-low power and lightweight electronics are enabling smarter technologies, from high-tech panties to EEG headsets.
Managing data, interoperability and cybersecurity issues were at the top of the list for industry stakeholders.
The technology platform has already gone global and has the potential to be a true breakthrough in screening and detecting several types of cancer.
One town in Pennsylvania is preparing for the Papal visit by equipping its various sites with defibrillators.