FDAnews Announces — New Management Report — Hack-Proofing Medical Devices: Ensuring Product Safety through Cybersecurity

Share Article

Can manufacturers prevent someone from hacking into their medical device? Hack-Proofing Medical Devices management report shows how to get and keep control of a devices’ networked operation.

Hack-Proofing Medical Devices:
Ensuring Product Safety through Cybersecurity
**An FDAnews Management Report**
http://www.fdanews.com/hackproofing    

How does the FDA expect devicemakers to fight cyber incursions?

With the recent release of the final guidance on postmarket management of cybersecurity, manufacturers now have advice from the agency.

The key is awareness of product vulnerabilities, current threats, developments in cybersecurity protection, how to defend from disastrous liability litigation and the list goes on.

Hack-Proofing Medical Devices will show readers how to get and keep control of their devices’ networked operations. The management report covers:

  •     Six environmental stressors that contribute to cybersecurity problems
  •     The overwhelming magnitude of the problem — 68,000 medical devices were found to be freely accessible through the Internet in 2015
  •     How the FDA and international regulators are handling issues involving software as a medical device (SaMD)
  •     Types of cybersecurity threats, including ransomware and device piggybacking
  •     How to determine the level of concern and exploitability for a particular device
  •     How to conduct device hazard analysis
  •     The FDA’s stance on cybersecurity as shown through recent guidances
  •     The kind of data and documentation manufacturers need to keep to protect against liability claims
  •     Key messages from the FDA delivered by CDRH’s Cybersecurity Program Manager

The report also provides a variety of tools including:

  •     A checklist for verifying a device’s cybersecurity controls status
  •     A sample medical device cybersecurity policy
  •     Spreadsheets that help assess level and severity of risk

Order Hack-Proofing Medical Devices and understand the nature of cybersecurity threats, how and where they occur and what manufacturers can do to prevent outside interference.

Who Will Benefit:

  •     IT specialists
  •     Design engineers
  •     Computer coders
  •     Quality control
  •     Regulatory affairs
  •     Legal affairs
  •     Liability lawyers

FDAnews Management Report Details:
Hack-Proofing Medical Devices:
Ensuring Product Safety through Cybersecurity
Price: $397
http://www.fdanews.com/hackproofing    

Easy Ways to Order:
Online:     http://www.fdanews.com/hackproofing            
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.

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Michelle Butler
FDANEWS
+1 (703) 538-7665
Email >
FDAnews
Like >
Visit website