By James Keller, Emergo Group Anyone paying even the slightest attention to today’s media has likely seen numerous reports on cybersecurity risks associated with medical devices. Some reports are overblown, some present more measured concern, and others describe very specific risks such as from major cyber-related product recalls. But there is an overall consensus among […]
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What cybersecurity compliance support should look like for medical device developers
By Ken Modeste, Emergo Group For healthcare product and medical device technology developers, ensuring effective support for cybersecurity compliance is becoming a key step in securing regulatory approval and market access. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not […]
Saudi Arabia regulators plan new MDMA fees, risk classification system for medical device registrants
By Stewart Eisenhart, Emergo Group Medical device market regulators in Saudi Arabia plan to raise registration fees as well as implement a new device regulatory system in the coming months. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily […]
Mexico medical device import permit application process goes fully online
By Stewart Eisenhart, Emergo Group The Mexican government will begin requiring electronic submission of all import permit applications starting September 24. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of DrugDeliveryBusiness.com or its employees.
Key Brexit-related issues for medical device, IVD sectors
By Stewart Eisenhart, Emergo Group Following UK Prime Minister Boris Johnson’s recent end-run around the British Parliament to truncate debate on avoiding a no-deal Brexit, the likelihood that the UK will withdraw from the European Union without significant economic safeguards in place on October 31, 2019 appears greater than ever. Get the full story here […]
Chinese regulators publish UDI system rules for medical device registrants
By Stewart Eisenhart, Emergo Group The National Medical Products Administration (NMPA), China’s medical device market regulator, has published official Unique Device Identification (UDI) requirements that will take effect October 1. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily […]
FDA requires more clarity on informed consent forms for clinical trials
By Stewart Eisenhart, Emergo Group A recent survey conducted by the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has revealed several areas in need of improvement, according to the agency. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
Italian IMQ becomes fourth MDR Notified Body
By Ronald Boumans, Emergo Group Last week there were already some rumors about Instituto Italiano del Marchio di Qualita S.P.A. (IMQ) being designated for the Medical Devices Regulation (EU) 2017/745 (MDR). Now this designation has been published in Nando. IMQ is the fourth Notified Body (NB) to be designated, after BSI Assurance UK Ltd, TÜV […]
Examining common medical device cybersecurity approaches in the U.S., Canada and Australia
By Marco Deuschler, Emergo Group The integration of advanced information technologies in medical devices has transformed the healthcare industry, resulting in dramatic improvements in the efficiency and effectiveness of healthcare and related services. But this integration has fostered the emergence of a new set of challenges for patients, healthcare providers, and device developers and manufacturers. […]
Medical device user research and design in the era of AI
By Mary Burton and Oliver Cook, Emergo Group For most of its young life as a technology discipline, user experience (UX) has been focused on graphical user interfaces or GUIs displayed within a variety of form factors (e.g., desktop computer monitor, mobile phone display, bedside monitor in a hospital). User research and design in software […]
