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 […]
KPMG
Report: Most medical device makers not ready to meet E.U. MDR deadline
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 […]
What you need to know about growing cyber threats to medtech
Medical devices are an especially rich cybersecurity target for malicious activity by those seeking commercial gain or just trying to wreak havoc. And while data theft is a serious threat, the risks posed by hacks that involve the expanding universe of networked medical devices can be especially menacing. Nach Davé and John Pappan, Premier Research […]
Are there hidden costs in the medical device tax?
Jason Rager may have the best job security in the world right now.
As the global tax director for Cook Medical, Rager is responsible for making sure the company is in compliance with the new medical device tax when it becomes law in January. It’s a tall order, to say the least.