By James Keller, Emergo Group That was the tagline for the 2019 Regulatory Affairs Professionals Society (RAPS) Convergence meeting in Philadelphia this September. As a first-time attendee of RAPS convergence, I could relate. However, for me, and I think for many of the other RAPS attendees, it was like drinking from a fire hose while […]
FDA updates telehealth and digital products guidance for medical device qualifications
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has updated and finalized guidance to determine which mobile medical applications fall under medical device oversight requirements based on their functions. 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 […]
This device can reactivate dead brains: Is it creepy or cool?
Scientists at Yale University have developed a device that can restore circulation and cellular activity in a pig’s brain four hours after death, raising ethical questions about the possibilities of one day applying it to humans. BrainEx is an open-source device originally based on CaVESWave, a system developed by Biomed Innovations of North Carolina to preserve donated organs for […]
FDA revokes voluntary malfunction reporting for some medical devices
By Marco Theobald, Registrar Corp. The U.S. Food and Drug Administration (FDA) recently updated the Voluntary Malfunction Summary Reporting (VMSR) program eligibility status of several medical device product codes. Some previously eligible devices are now ineligible for VMSR, meaning manufacturers must now submit standard individual Medical Device Reports (MDRs) for the newly ineligible products. FDA […]
TÜV Rheinland becomes fifth designated Notified Body under EU MDR
By Stewart Eisenhart, Emergo Group Germany’s TÜV Rheinland has received designation to issue CE Mark certificates under the European Medical Devices Regulation (MDR), raising the total number of Notified Bodies with MDR designation to five. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
RAPS compliance issues for compiling clinical evaluation reports
By James Keller, Emergo Group The Regulatory Affairs Professionals Society (RAPS) Convergence conference recently held in Philadelphia covered various regulatory issues affecting medical device and technology sectors. Compliance challenges pertaining to clinical data management and Clinical Evaluation Reports (CER) constituted one such area of focus. Get the full story here at the Emergo Group’s blog. […]
FDA advances conformity assessment accreditation pilot program
By Stewart Eisenhart, Emergo Group New guidance from the US Food and Drug Administration establishes a highly anticipated pilot program for voluntary conformity assessments to improve premarket reviews. 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 […]
MHRA clarifies U.K. REP role in post-Brexit medical device market
By Ronald Boumans, Emergo Group The Medicines and Healthcare products Regulatory Agency (MHRA), Great Britain’s medical device market regulator, has published new details on the role and responsibilities of the UK Responsible Person if a no-deal Brexit withdrawal from the European Union comes to pass. Get the full story here at the Emergo Group’s blog. […]
Emergo Group launches new RAMS digital medical device RA/QA management system
By Stewart Eisenhart, Emergo Group Emergo by UL has rolled out an enhanced version of its Regulatory Affairs Management Suite (RAMS) platform to provide automated, efficient and cost-effective regulatory affairs and quality management support for medical device companies. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
FDA finalizes guidance on special and abbreviated 510(k) programs
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has issued final guidance for its Special and Abbreviated 510(k) premarket notification pathways following proposals in 2018 to expand access to these programs, as well as its Refuse to Accept policy for inadequate or incomplete 510(k) submissions. […]
EU Commission lays out plan on expert panels under MDR, IVDR
By Stewart Eisenhart, Emergo Group The European Commission has clarified its designation process for appointing expert panels to support regulators, Notified Bodies and other entities meet requirements and obligations of 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 […]
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