Impact of EU MDR on Notified Bodies

As medical device companies are beginning to transition towards the EU Medical Device Regulation standards, there is no denying that Notified Bodies are also making strides to meet the May 2020 deadline. According to a recent article, the new regulations include...

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Understanding the FDA Cybersecurity Go-Team

Understanding the FDA Cybersecurity Go-Team

The U.S. Food and Drug Administration (FDA) recently unveiled the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health, a comprehensive plan with the goal of assessing processes and procedures in order to enhance medical device security in an ever-evolving technological landscape.

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From On-Screen To Real Life

From On-Screen To Real Life

The US Food and Drug Administration (FDA) recently released a new medical device safety action plan that contains five focus areas that aim to improve the quality of real-world evidence, improve post-market surveillance, spur innovation around safer devices, advance cybersecurity initiatives and reorganize the Center for Devices and Radiological Health (CDRH).

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7TH ANNUAL PHARMACEUTICAL REGULATORY OPERATIONS AND SUBMISSIONS PUBLISHING STRATEGIES CONFERENCE

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12TH SEMI-ANNUAL LIFE SCIENCE CFO STRATEGIC GOVERNANCE FORUM

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14TH ANNUAL MEDICAL DEVICE COVERAGE AND REIMBURSEMENT CONFERENCE

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2ND ANNUAL EU MDR IMPLEMENTATION CONFERENCE

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Concussions Can Be Detected With New Blood Test Approved by F.D.A.

The Food and Drug Administration on Wednesday approved a long-awaited blood test to detect concussions in people and more quickly identify those with possible brain injuries.

The test, called the Banyan Brain Trauma Indicator, is also expected to reduce the number of people exposed to radiation through CT scans, or computed tomography scans, that detect brain tissue damage or intracranial lesions. If the blood test is adopted widely, it could eliminate the need for CT scans in at least a third of those with suspected brain injuries, the agency predicted. Read the full story here.

FDA releases top 3 medical device regulation goals

Setting goals helps everyone do better. The FDA is no different. They have released the top 3 device regulation goals for the next three years. These include improving employee engagement, increasing simplicity and building collaborative communities. To read more about the strategies being put in place, click here.

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