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 […]
Emergo Group
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 […]
European Notified Body capacity update ahead of MDR, IVDR and Brexit
By Ronald Boumans, Emergo Group The European Notified Body (NB) landscape remains in uncertain territory as additional entities opt-out of designation to the Medical Devices Regulation (MDR) and In-vitro Diagnostic Devices Regulation (IVDR), with ongoing lack of resolution regarding Brexit continuing to have an impact as well. Get the full story here at the Emergo […]
European Commission clarifies medical device vigilance requirements
By Stewart Eisenhart, Emergo Group The European Commission has published new guidance clarifying manufacturers’ obligations under the Medical Device Vigilance System established by the Medical Devices Directive (MDD). 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 […]
How human factors validation investigators identify user groups and populations
By Ella Engels, Emergo Group Imagine you are preparing for a human factors (HF) validation study to bring your medical device to market, and the market research recruiters inform you that it will be very challenging, if not unfeasible, to recruit the required 15 participants per user group. What do you do? Get the full […]
European Commission publishes guidance on responsible person requirements under MDR, IVDR
By Stewart Eisenhart, Emergo Group European regulators have published new guidance documents addressing persons responsible for managing compliance with the Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR). 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 […]
China NMPA releases new eRPS medical device registration system details
By Stewart Eisenhart, Emergo Group Emergo by UL has learned additional details regarding the China National Medical Product Administration’s (NMPA) new electronic medical device registration management (eRPS) 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 those […]
FDA issues final rule for appealing medical device regulatory decisions
By Stewart Eisenhart, Emergo Group A final rule recently issued by the US Food and Drug Administration explains procedures and timeframe requirements whereby regulatory decisions by the agency’s Center for Devices and Radiological Health (CDRH) may be appealed. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
Australia regulators publish guidance on recognized QMS standards
By Kate Jablonski, Emergo Group The Australia Therapeutic Goods Administration (TGA) published guidance on its recent update to Medical Device Standards Order (MDSO), Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019, on June 19. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]