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Blogs | INSIGHTS | August 20, 2013

FDA Medical Device Guidance

Last week the US Food and Drug Administration (FDA) finally released a couple of important documents. The first being their¬†guidance on using radio frequency wireless technology in medical devices¬†(replacing a draft from January 3,2007), and a second being their new (draft) guidance on premarket submission for management of cybersecurity in medical devices. The wireless technology guidance document seeks to address many of the risks and vulnerabilities that have been disclosed in medical devices (embedded or otherwise) in recent years – in particular those with embedded RF wireless functionality…

Gunter Ollmann
Blogs | INSIGHTS | June 20, 2013

FDA Safety Communication for Medical Devices

The US Food and Drug Agency (FDA) released an important safety communication targeted at medical device manufacturers, hospitals, medical device user facilities, health care IT and procurements staff, along with biomedical engineers in which they warn of risk of failure due to cyberattack – such as through malware or unauthorized access to configuration settings in medical devices and hospital networks.   Have you ever been to view a much anticipated movie based upon an exciting book you happened to have read when you were younger, only to be sorely disappointed…

Gunter Ollmann

Thoughts on Supply Chain Integrity

In this video presentation, John Sheehy, VP, Sales and Strategy at IOActive, shares his comprehensive view on the myriad considerations facing business as they undertake supply chain integrity assessments, focused on securing operations.

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IOACTIVE CORPORATE OVERVIEW (PDF)