The agency clarifies some misconceptions about requirements.
No medical device is 100% secure.
A three-part series on quality system remediation and what manufacturers need to do to get through the process.
The final guidance is part of the agency’s effort to provide better patient access to new devices via stronger and streamlined clinical trials.
If exploited, unauthorized access to these devices could have dangerous consequences.
Device manufacturers need to identify, monitor and address cybersecurity vulnerabilities as part of postmarket device management.
Infusion errors, faulty cleaning of devices and missed alarms are among ECRI’s annual list of dangers surrounding healthcare products for 2017.
The expanding international market poses a variety of challenges for medtech companies entering new global territories.
You can never do enough due diligence.
Although results don’t need to be shared with FDA during an inspection, an audit still should be performed.