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RAPS meeting highlights medical device regulatory challenges

October 16, 2019 By MassDevice

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 […]

Filed Under: Blog Tagged With: Emergo Group

FDA updates telehealth and digital products guidance for medical device qualifications

October 15, 2019 By MassDevice

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 […]

Filed Under: Blog Tagged With: Emergo Group

FDA revokes voluntary malfunction reporting for some medical devices

October 11, 2019 By MassDevice

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 […]

Filed Under: Blog, Food & Drug Administration (FDA) Tagged With: Registrar Corp.

TÜV Rheinland becomes fifth designated Notified Body under EU MDR

October 4, 2019 By MassDevice

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 […]

Filed Under: Blog Tagged With: Emergo Group

RAPS compliance issues for compiling clinical evaluation reports

October 3, 2019 By MassDevice

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. […]

Filed Under: Blog Tagged With: Emergo Group

FDA advances conformity assessment accreditation pilot program

October 2, 2019 By MassDevice

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 […]

Filed Under: Blog Tagged With: Emergo Group

I’m a medtech expert who survived a tumor in my head

October 1, 2019 By MassDevice

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 […]

Filed Under: Featured, Neurological, News Well, Research & Development Tagged With: Betten Systems Solutions, DeviceTalks Minnesota

MHRA clarifies U.K. REP role in post-Brexit medical device market

October 1, 2019 By MassDevice

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. […]

Filed Under: Blog Tagged With: Emergo Group

Emergo Group launches new RAMS digital medical device RA/QA management system

September 30, 2019 By MassDevice

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 […]

Filed Under: Blog Tagged With: Emergo Group

FDA finalizes guidance on special and abbreviated 510(k) programs

September 24, 2019 By MassDevice

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. […]

Filed Under: Blog Tagged With: Emergo Group

Medical Tubing and Extrusion: Check it out

August 27, 2019 By MassDevice

WTWH Media is pleased to announce the newest media site in its Life Sciences business. Medical Tubing + Extrusion is your go-to source for news about innovations in the medical tubing and extrusion space — and the companies making those advances possible. Part of WTWH Media, the site is a resource of Medical Design & Outsourcing and MassDevice. “In the past […]

Filed Under: Contract Manufacturing, Featured, News Well Tagged With: WTWH Media

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