Ireland has a who’s-who list of life sciences companies: Medtronic, Baxter Healthcare, Becton Dickinson, Cook Medical, Allergan, Zimmer Biomet, and Abbott Vascular are among the major medical device manufacturers with locations in the Emerald Isle. With a workforce of 25,000 in the sector, Ireland is home to nearly 350 device companies (13 of the top 15 global device companies have a facility in the country), according to Michael Lohan, department head of medical technology and healthcare services at IDA Ireland. During a discussion with MedTechIntelligence during the AdvaMed 2015 conference last month, Lohan mentioned that within the last 18 months, medtech companies have made about $650 million in investments in Ireland. Lohan shares some of the advantages of doing business in the country, which continues to grow its infrastructure for providing global medical device manufacturing services, in the video.
(Note: Please bear with the wind at the beginning of the video)
The UK MHRA has published “Software and Artificial Intelligence as a Medical Device.” The guidance document assembles previous guidances and regulatory requirements for SaMD and AIaMD devices seeking commercialization in the UK market.
“Addressing unmet needs across pediatric populations is critical to advancing children’s health, and we are delighted to once again work with pioneering companies that seek to bridge this care gap."
The MDDT program was developed in collaboration with the National Institutes of Health’s (NIH’s) National Institute of Drug Abuse (NIDA), National Institute of Dental Craniofacial Research (NIDCR) and National Cancer Institute (NCI) as a way for the FDA to qualify…
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