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 […]

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 […]

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 […]

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 […]

By Stewart Eisenhart, Emergo Group The South Korean Ministry for Food and Drug Safety (MFDS) has established new regulations for registration of IVD products in order to improve oversight of these devices’ safety and quality, according to the agency. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog […]

By Stewart Eisenhart, Emergo Group The Korea Medical Devices Industrial Cooperative Association (KMDICA), a South Korean medical device industry association, has partnered with global regulatory consulting firm Emergo by UL to provide European market compliance support to the group’s more than 500 member companies. Get the full story here at the Emergo Group’s blog. The […]

By Stewart Eisenhart, Emergo Group The US Food and Drug Administration’s medical device oversight division has ended reporting exemptions for some manufacturers and made more report data publicly available in an effort to boost transparency and better monitor product safety. Get the full story here at the Emergo Group’s blog. The opinions expressed in this […]

By Stewart Eisenhart, Emergo Group A new factsheet from the European Commission advises healthcare providers and institutions to prepare for possible shortages of some medical devices and IVDs in the event that manufacturers do not meet compliance deadlines for the Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR). Get the full story […]

By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA recently discussed revisions to planned requirements for custom-made devices with Emergo by UL consultants prior to finalization and official publication of the new rules. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]