The Centre of Excellence will encourage innovation in the field of digital health & AI as well as safeguarding users. Digital health products, from smartphone apps to AI-enhanced diagnostic devices, are increasingly beneficial for patients and healthcare professionals alike – and the UK is a global
Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, an advisor to MedTech suppliers, chair of the Urology Trade Association, and governor of the Anscombe Bioethics Centre, highlights a new Anglo/Indian agreement to boost coope
MRC Holland has announced that its Melt Assay SALSA MC002 SMA Newborn Screen was recently CE-marked for in vitro diagnostic (IVD) use under the new In-Vitro Diagnostic Regulation EU 2017/746 (IVDR). This makes it the company’s first product to be added to the IVDR certificate. The company says this
Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, an advisor to MedTech suppliers, chair of the Urology Trade Association, and governor of the Anscombe Bioethics Centre, looks at the opportunity for digital devices, assistiv
Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, an advisor to MedTech suppliers, chair of the Urology Trade Association, and governor of the Anscombe Bioethics Centre, highlights a major step in making the NHS a digital fi
ZEISS Medical Technology has announced that its MEL 90 device has received approval from the U.S. Food and Drug Administration (FDA), giving the excimer laser technology simultaneous approval for all three major indications, including myopia, hyperopia and mixed astigmatism (a condition where both h
Laura Friedl-Hirst, Founder, Managing Director and Principal Consultant at LFH Regulatory discusses the main regulatory changes in the UK and the EU over the past 12 months. The requirements for medical device and in vitro diagnostic are constantly evolving, especially with changes such as the Unite
Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, an advisor to MedTech suppliers, chair of the Urology Trade Association, and governor of the Anscombe Bioethics Centre, looks ahead at what the coming year holds for the MedT
Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, an advisor to MedTech suppliers, highlights a new UK Government agency consultation on medical devices regulation.
Packaging specialist at Sumitomo (SHI) Demag UK Ashlee Gough examines the latest techniques being deployed to counteract these infringements and different methods to safeguard product and named-brand integrity.