Why create the MDSAP? Since the foundation of the Global Harmonisation task force in 1993, medical device institutional bodies have been working to bring uniformity and simplicity to international accreditation, removing barriers to increased trade and improving patient access to...
The answer is a resounding “well, it depends…” It depends on many factors including the specific circumstance, position, timelines and ambitions you have for your device and your company. This article summarises some of the key differences, positives and negatives...
The coronavirus outbreak has caused unprecedented levels of chaos and disruption around the world. As the global need for protective equipment, intensive care and infection prevention has grown exponentially, the medical device industry has become instrumental in the battle...
Since the beginning of the 21st century, we‘ve seen a massive upsurge of innovative combinations between drugs, devices, biologics, and most recently software and AI. Drug-eluting implants, ingestible electronics, smart pacemakers, insulin pumps, patches and all sorts of wearables...
“Biology and Technology are evolutionary processes in which the information processing tools of prior generations are used to make those of the next. As these tools improve, the time between advances in order and capability decreases exponentially” – Ray...

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