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Beyond the regulatory requirement to perform them, regular internal audits can benefit quality, productivity and an organization’s bottom line. But if you’re simply going through the motions of an internal audit to check that regulatory box or if you’re not properly analyzing the data that comes out of those audits, you’re missing a real opportunity, says quality expert says Steven Lynn, executive vice president of pharmaceuticals at Regulatory Compliance Associates. Read More
Medtronic’s June recall of its Mahurkar Acute Triple Lumen and Mahurkar Acute High Pressure Triple Lumen Catheters, the third recall of the company’s hemodialysis catheters in a year, has been deemed class I by the FDA, because use of the device could cause serious injury or death. Read More
Make sure to submit electronic or written comments on a guidance by the closing date is the first tip given by CDRH in a list, released Aug. 16, of tips, recommendations and instructions on how to submit comments on a guidance. Read More
The FDA has classified the most recent recall of certain Philips Trilogy ventilators as class I, the most serious type of recall as use of the device may lead to serious injury or death. Read More
Incorporating off-the-shelf (OTS) software into medical devices is becoming more common but a new guidance from the FDA advises that when using prepared software from another manufacturer, devicemakers still bear responsibility for continued safe and effective performance of the device. Read More
Illumina received notice in July that the Securities and Exchange Commission (SEC) was conducting an investigation into the company’s acquisition of Grail, requesting documents from the company over the beleaguered acquisition. Read More
In July, the court said that PTAB used incorrect legal framing and conducted an erroneous obviousness analysis in its opinion on separate but related Medtronic patents. Read More
Extended timelines alone are not sufficient to achieve transition to the new European medical device regulations, Team NB — the European Association of Medical devices Notified Bodies — says in a position paper it issued Thursday, explaining that manufacturers are still lagging in applying for certification. Read More