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Pharma 5.0
Unlocking potential through regulation: the AI revolution in medical devices
The healthcare industry is entering a transformative era with the emergence of digital technologies. Innovations such as wearable sensors to monitor vital signs and AI-powered diagnostic tools are poised to revolutionise healthcare delivery. However, navigating the evolving regulatory landscape remains a significant challenge
Regulatory
IMed launches new whitepaper exploring regulatory challenges for AI and ML in medical devices and digital health products
IMed Consultancy shares free paper assessing the regulatory state of play for artificial intelligence (AI) and machine learning (ML)-powered medical devices in the UK, US and EU
Regulatory
The key role of IVDs in healthcare: challenges to commercialisation and access
In simple terms, in vitro diagnostic (IVD) tests are done on samples such as blood or tissue that have been taken from the human body. IVDs can detect diseases, conditions and infections, provide patients with a better understanding of their ailment and how it might be managed and changed with treatment
Regulatory
The entry conundrum for every medical device: which market first?
Regulatory bodies around the world are tackling the concerns raised by new technologies as well as seeking ways to accelerate the opportunities they provide to support patients, reports Leeanne Baker, Managing Director and Senior QA/RA Consultant at IMed Consultancy
Regulatory
Unlocking opportunities: entering the UK medical device market successfully
In the changing landscape of European medical device regulations, the UK remains an attractive destination for US and foreign businesses. Unlike the European Union (EU), the UK continues to operate within its consolidated regulatory framework, thereby positioning itself as an ideal market for novel and niche products