FDA Squashes Five Cybersecurity Myths
The agency clarifies some misconceptions about requirements.
Tag Archives: risk
It’s Impossible to Eliminate Cybersecurity Threat
No medical device is 100% secure.
Remediation: What Challenges Do Device Companies Face?
A three-part series on quality system remediation and what manufacturers need to do to get through the process.
FDA’s Guidance Clears Up Factors, Benefits and Risks for IDE Submissions
The final guidance is part of the agency’s effort to provide better patient access to new devices via stronger and streamlined clinical trials.
FDA Confirms Cybersecurity Vulnerabilities with Certain St. Jude Medical ICDs
If exploited, unauthorized access to these devices could have dangerous consequences.
FDA Releases Final Guidance on Postmarket Cybersecurity
Device manufacturers need to identify, monitor and address cybersecurity vulnerabilities as part of postmarket device management.
Patient Risk: ECRI Releases Top 10 Health Tech Hazards
Infusion errors, faulty cleaning of devices and missed alarms are among ECRI’s annual list of dangers surrounding healthcare products for 2017.
Mitigating Global Supply Chain Risks
The expanding international market poses a variety of challenges for medtech companies entering new global territories.
Minimize Acquisition Risk in Asia
You can never do enough due diligence.
What, No Internal Audits?
Although results don’t need to be shared with FDA during an inspection, an audit still should be performed.
