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European Commission Provides Important Guidance on Qualification and Classification of Software Under New Medical Devices Regulations

Data Matters

The Guidance seeks to provide clarification to medical software manufacturers with respect to (i) when software is considered a device (qualification) and (ii) what risk category the device falls into (classification). 6, 2 most software devices are classified as low risk. Key Points to Highlight.

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Proposed Changes to FDA Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: What you Should Know

HL Chronicle of Data Protection

The new draft premarket cybersecurity guidance provides information designed to aid manufacturers in determining how to meet the agency’s expectations during premarket review of medical devices. Risk-based design, validation, and the CBOM. the significance of the new HDO playbook.

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Supply Chain Security 101: An Expert’s View

Krebs on Security

The event Sager and I spoke at was prior to the publication of Bloomberg Businessweek ‘s controversial story alleging that Supermicro had duped almost 30 companies into buying backdoored hardware. TS: The government still has regular meetings on supply chain risk management, but there are no easy answers to this problem.

Security 210
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The NewCo-BigCo Shift or, These Nine Things Will Change Business Forever

John Battelle's Searchblog

but NewCos — even the very largest ones like Google — most definitely are. Regardless of good intent or excellent marketing, if your business makes people unhealthy, or depends on exploitation of vulnerable workers, or can be laddered to climate change, it’s at risk of mass consumer migration to businesses with better narratives.

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The Hacker Mind Podcast: Hacking Industrial Control Systems

ForAllSecure

So there’s a need, a definite need, for information security professionals to have access to industrial control systems -- not virtual, but actual hands on systems -- so they can learn. Kim Zetter’s book, Countdown to Zero Day, is perhaps the definitive book on the subject. Van Norman: Right right.

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Network Protection: How to Secure a Network

eSecurity Planet

Definition, Threats & Protections 10 Network Security Threats Everyone Should Know Overall Network Security Best Practices Best practices for network security directly counter the major threats to the network with specific technologies and controls. Better network security access controls can improve security and decrease cost and risk.

Security 107
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The Hacker Mind: Shattering InfoSec's Glass Ceiling

ForAllSecure

Definitely helps and for especially for folks who are more high profile in the industry, you should take a stand you need to make make a statement and into work. Make the event organizers know your position on this. So I just don't know, statistically speaking, no, which category is better. And I think this is changing.

Cloud 40