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. […]
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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 DrugDeliveryBusiness.com or its employees.
Australian TGA issues final guidance on medical device and IVD cybersecurity
By Stewart Eisenhart, Emergo Group Australia’s Therapeutic Goods Administration (TGA) has implemented final guidance on pre- and post-market cybersecurity regulatory recommendations for medical device, software and IVD manufacturers and sponsors. 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 […]
New European MDR guidance on medical device implant cards
By Ronald Boumans, Emergo Group The European Medical Device Coordination Group (MDCG) has adopted a guidance document on implant cards, assisting in understanding article 18 of the Medical Devices Regulation (EU) 2017/745 (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 […]
Brazil regulators require electronic submission of medical device FSCAs
By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA has begun requiring manufacturers and sponsors to provide field safety corrective action information via an electronic petitioning system. 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 […]
Chinese regulators preparing medical device UDI pilot
By Stewart Eisenhart, Emergo Group The National Medical Products Administration (NMPA), China’s medical device market regulator, has begun laying the groundwork for a Unique Device Identification (UDI) pilot program scheduled to run through July 2020. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
