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Building Cybersecurity into the Development Process Management Report

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WCG FDAnews

WCG FDAnews


FALLS CHURCH, Va. (PRWEB)

Designing Secure Medical Devices:

Building Cybersecurity into the Development Process

https://www.fdanews.com/products/62026

Are connected medical devices protected from cybersecurity threats? If they’re connected to networks, other devices or the internet, they’re vulnerable to attacks that can impact their safety and effectiveness.

Designing Secure Medical Devices: Building Cybersecurity into the Development is your solution.

To obtain marketing authorization from the FDA and other regulators, one must demonstrate that the risks and vulnerabilities of the products have been examined at every single step of the development process. Security measures, firewalls and fail-safe functions must be built in to protect users from falling victim to hackers. Designing Secure Medical Devices explains how to do all of this.

The U.S. Department of Health and Human Services listed medical devices as one of the top five cybersecurity threats: the smallest tampering or most innocent error can cost lives.

But when 70% of devices are estimated to be running outdated, no-longer-supported Windows operating systems — which may have critical vulnerabilities for which a patch was long-ago available — you have your work cut out for you.

Designing Secure Medical Devices is cybersecurity insurance.

Management report takeaways:

  • How cybersecurity relates to design controls specifically and the quality system more generally

  • Key tips for explaining and defending cybersecurity measures during an FDA or other regulatory inspection

  • How to educate investigators and auditors unfamiliar with cybersecurity issues

  • How addressing cybersecurity risk relates to product risk management

  • Common cybersecurity issues identified during inspections and submission reviews

  • How to incorporate cybersecurity documentation into a device’s design history file

Don’t ignore this threat. Stay compliant, protect the devices — and protect patients — with Designing Secure Medical Devices: Building Cybersecurity into the Development Process.

Management Report Details:

Designing Secure Medical Devices:

Building Cybersecurity into the Development Process

https://www.fdanews.com/products/62026

Price:

$397

Easy Ways to Order:

Online: https://www.fdanews.com/products/62026

By phone: 888.838.5578 or 703.538.7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations

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