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RAPS

KPMG/RAPS survey highlights MDR barriers

September 30, 2019 By Sean Whooley

According to a survey conducted by KPMG and the Regulatory Affairs Professionals Society (RAPS), achieving MDR compliance by the May 2020 deadline remains difficult for companies, mainly due to a lack of resources. The survey, which closed on June 21 this year, takes into account the responses from 230 medical device organizations, 91% of which […]

Filed Under: Regulatory/Compliance Tagged With: KPMG, RAPS

Report: Most medical device makers not ready to meet E.U. MDR deadline

September 24, 2019 By Chris Newmarker

Only about a fourth of medical device companies plan to be fully compliant with the European Union’s new Medical Device Regulation when it goes into effect on May 26, 2020, according to a new survey from the Regulatory Affairs Professionals Society (RAPS) and KPMG. The survey — which closed in late June and was released […]

Filed Under: Featured, News Well, Regulatory/Compliance Tagged With: EU MDR, European Union, KPMG, RAPS

7 medtech stories we missed this week: May 5, 2017

May 5, 2017 By Danielle Kirsh

From Biomerics’s $38.5 million expansion in Salt Lake City to new study results and partnerships, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Biomerics opening new corporate HQ Biomerics announced in a May 1 press release that it is moving its corporate headquarters in Salt Lake City. The […]

Filed Under: Clinical Trials, Food & Drug Administration (FDA), Imaging, Pre-Market Approval (PMA), Regulatory/Compliance, Research & Development Tagged With: Accuray Inc., Biomerics, Glytec, medPhoton, MedTech, Mevion Medical Systems, Neural Analytics, RAPS, Refocus

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