By Stewart Eisenhart, Emergo Group A fast-track premarket review pathway for some medical devices in Egypt is yielding substantially reduced time to market for qualifying manufacturers. 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 […]

By Ronald Boumans, Emergo Group The U.K. government has requested a further delay in implementing its withdrawal from the European Union, with an April 12 deadline for a no-deal Brexit outcome fast approaching. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]

By Stewart Eisenhart, Emergo Group Canadian medical device regulator Health Canada has issued a clarification on which changes to Medical Device License (MDL) holders’ sterilization processes constitute “significant changes” following the closure of a major sterilization facility in the US earlier in 2019. Get the full story here at the Emergo Group’s blog. The opinions […]

By Mark Leimbeck, Emergo Group Medical device design and development processes in the context of risk management require careful consideration and planning by manufacturers. Following our webinar in early 2019, we explore five key issues companies face when linking design and development with risk management and, ultimately, patient safety. Get the full story here at […]

By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has identified nearly 600 types of medical devices possibly impacted by the recent shutdown of a sterilization facility in the midwestern US, and states that a second sterilization facility will also close this year. Get the full story here at the Emergo Group’s blog. […]

By Stewart Eisenhart, Emergo Group Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has increased registration, inspection and related regulatory fees for medical device market applicants. 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 […]

By Erin Davis and Allison Strochlic, Emergo Group Manufacturers, consultants, researchers, and regulators all descended upon Chicago this week for the annual Human Factors and Ergonomics Society Health Care Symposium. After taking in dozens of oral presentations and hundreds of posters, attendees often walk away from the event feeling invigorated that there are so many […]

By Stewart Eisenhart, Emergo Group Following Emergo by UL’s recent webinar on the European Union’s General Data Protection Regulation (GDPR) and human factors studies for medical devices, we examine key GDPR compliance issues human factors researchers must address to avoid steep penalties. The webinar was presented by Allison Strochlic and Alexandria Trombley, Research Director and […]

By Stewart Eisenhart, Emergo Group US medical device regulators are planning more focused evaluations of materials used in the manufacture of medical devices for safety issues. 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 […]

By Stephanie Larson and Richard Featherstone, Emergo Group Nicotine replacement therapy (NRT) drug products, such as patches, gum and lozenges, have been around for more than 30 years. More novel products such as e-cigarettes provide additional choices for people using NRT for smoking cessation. But, like any other drug delivery mechanism, there are risks as […]

By Ronald Boumans, Emergo Group The United Kingdom (UK) may leave the European Union (EU) on 29 March 2019. The draft agreement on Brexit has not yet been ratified by the UK and the EU parliaments. The Netherlands and the EU are therefore still preparing for various scenarios. One of those scenarios is that no […]