By Stewart Eisenhart, Emergo Group Final guidance from the US Food and Drug Administration pushes back enforcement deadlines for certain Unique Device Identification (UDI) requirements for Class I and unclassified medical devices due partially to the agency’s coronavirus pandemic-related priorities. Get the full story here at the Emergo Group’s blog. The opinions expressed in this […]
Medtronic seeks to boost surgical robotics play with Digital Surgery acquisition
Medtronic (NYSE:MDT) announced today that it has acquired Digital Surgery (London), a privately-held pioneer in surgical artificial intelligence, data and analytics, and digital education and training. Financial terms of the deal were not disclosed. Medtronic said the purchase will strengthen its robot-assisted surgical platform and its broader portfolio. The medical device giant is making a big play […]
How to Successfully Manage Compliance for EU MDR
As the May 2020 deadline approaches, manufacturers and suppliers are forced to comply or be faced with major implications on their business. The following report outlines a path to compliance and how to: Identify if your company is on course for compliance Manage the 11 new label elements on a global scale Overcome the challenges […]
RAPS meeting highlights medical device regulatory challenges
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 […]
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 […]
I’m a medtech expert who survived a tumor in my head
More than five months into a successful recovery from surgery to remove a golfball-sized meningioma, medtech industry veteran Bill Betten reflects on lessons learned. Bill Betten, Betten Systems Solutions A neurosurgeon walks into the room and says, “So you’re the interesting case.” Not exactly words one wants to hear, but the scientist and engineer inside […]
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. […]
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