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. […]
Emergo Group
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 […]
Key questions for medical device companies to tackle gaps in cybersecurity processes
By James Keller, Emergo Group Anyone paying even the slightest attention to today’s media has likely seen numerous reports on cybersecurity risks associated with medical devices. Some reports are overblown, some present more measured concern, and others describe very specific risks such as from major cyber-related product recalls. But there is an overall consensus among […]
What cybersecurity compliance support should look like for medical device developers
By Ken Modeste, Emergo Group For healthcare product and medical device technology developers, ensuring effective support for cybersecurity compliance is becoming a key step in securing regulatory approval and market access. 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 […]
Saudi Arabia regulators plan new MDMA fees, risk classification system for medical device registrants
By Stewart Eisenhart, Emergo Group Medical device market regulators in Saudi Arabia plan to raise registration fees as well as implement a new device regulatory system in the coming months. 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 […]
Mexico medical device import permit application process goes fully online
By Stewart Eisenhart, Emergo Group The Mexican government will begin requiring electronic submission of all import permit applications starting September 24. 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 its employees.
Key Brexit-related issues for medical device, IVD sectors
By Stewart Eisenhart, Emergo Group Following UK Prime Minister Boris Johnson’s recent end-run around the British Parliament to truncate debate on avoiding a no-deal Brexit, the likelihood that the UK will withdraw from the European Union without significant economic safeguards in place on October 31, 2019 appears greater than ever. Get the full story here […]