Orthotaxy’s Technology Will Be Leveraged to Develop Cost-Effective, Time-Efficient, User-Friendly Offering in a Broad Range of Orthopaedics Procedures.
The US Food and Drug Administration (FDA) on Tuesday finalized a rule that requires medical device clinical investigations conducted outside the US to flexibly conform with good clinical practice (GCP) standards.
On February 6, 2018, the China Food and Drug Administration (CFDA) and its Center for Medical Device Evaluation (CMDE) issued a draft guidance entitled “Guidance on the Review of Medical Devices for Preventing and Treating Rare Diseases.” The draft guidance is based on the reform measures recently outlined in the government’s broad blueprint for drug and device reform—the Opinion on Strengthening the Reform of the Drug and Medical Device Review and Approval Process to Encourage Drug and Medical Device Innovation (“Opinion 42”).
Managing your medical device product development project can be a daunting task. There are regulations and paperwork to manage, along with expectations such as deadlines or goals for getting the device to market.
Materials are one of the most common causes of failure in medical devices, especially for plastic. Records show that material failure is responsible for 30 to 40 percent of all FDA recalls on medical devices.
Have you made your schedule for 2018? Take some time to consider your options and see what Ddu has planned this February!
It is a disturbing, but true fact that medical devices are hacked. Medical devices have inbuilt software, and hackers try to breach this. Medical device cybersecurity is thus critical, because lack of it can bring harm to patients who use medical devices that come with software built into them.
Used medical equipment is often a smart and cost-effective way of acquiring medical device products. Everything from diagnostics to monitoring medical equipment is available online for second hand purchasing but there are a couple of things to look out for and consider when investing in these products. From first-hand experience, Drugdu.com has created a list of what to look out for and what to keep in mind.
With the recent, highly publicized incidents of identity theft, ransomware and malware attacks directed at healthcare facilities, the medical device community is on high-security alert.
Accidents happen and emergencies arise in every office and in every industry and being prepared for situations such as these is vital.
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