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 […]
Emergo Group
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 […]
How medical device early-use research and testing affects product design and development
By Andrew Micek, Emergo Group Many medical device companies have learned over recent years that early-use testing is not simply optional, but rather an important means to save time, money and effort during product development. But other firms that are less familiar with the process and still learning to understand the importance of such work. […]
IMDRF publishes Conformity Assessment Body recognition requirements
By Stewart Eisenhart, Emergo Group The International Medical Device Regulators Forum (IMDRF) has published recommendations to establish more specific criteria whereby market regulators recognize conformity assessment bodies (CABs) for conducting premarket reviews of devices and IVDs. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
FDA finalizes post-market safety reporting guidance for combination products
By Stewart Eisenhart, Emergo Group Final guidance issued by the US Food and Drug Administration explains how combination product manufacturers should comply with post-market safety reporting requirements originally established in late 2016. 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 […]
Implications for Internet of Bodies on implanted medical devices
By Michael Wiklund and Richard Featherstone, Emergo Group The term Internet of Things (aka IoT) entered the lexicon in 1999. Since then, there has been a proliferation of related terms, such as the Web of Things (WoT) and Internet of Medical Things (IoMT). We recently heard the term Internet of Bodies (IoB), and it really […]
FDA adds AAMI/UL 2800 standards for medical device interoperability
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has added a new standard developed by AAMI, ANSI and UL for safety of interoperable medical devices to its list of recognized consensus standards, providing a tool for manufacturers of interoperable products to demonstrate safety as well as cybersecurity risk management. Get the full […]
DEKRA receives Notified Body designation for EU Medical Devices Regulation
By Ronald Boumans, Emergo Group DEKRA Certification GmbH, NB number 0124, is now designated for the Medical Devices Regulation (EU) 2019/745 (MDR). 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 MassDevice.com or its employees.