OPENREGULATORY
Sign in Get started

SoftwareCPR

FDA Cybersecurity

SoftwareCPR is a Tampa-headquartered regulatory consulting firm specializing in medical device and health-technology software. Its partners support FDA submission readiness and prepare software, firmware, cybersecurity and interoperability sections for 510(k), PMA and IDE filings. The firm also advises on SaMD development, software lifecycle processes, risk management, cybersecurity assessments, verification, quality-system audits and responses to FDA enforcement actions.

Learn more

A

Are there FDA requirements for non-device clinical decision support software?

Anonymous · 1 comment
5 months ago
According to the new FDA guidance on clinical decision support software, our software is classified as a non-device. What are the requirements for bringing such software to the US market? Are there st
Accepted 1 answer

If your assessment shows that your product is truly a “non-device” according to the FDA guidance, there aren’t specific FDA requirements you need to m

A

What is my company's role under MDR when incorporating a CE-marked software medical device from another manufacturer into our non-medical app?

Anonymous · 2 comments
8 months ago
I am planning to incorporate a CE-marked software solution (manufactured by another company) into our app, which itself is not a medical device. The software will be made directly available to our use
Accepted 2 answers

We were in a similar situation and the competent authorities defined our role as a distributor. If you are making the CE-marked software medical devic

A

Is internally used diagnostic software considered a medical device under MDR?

Anonymous · 1 comment
5 months ago
Our company has developed three software components related to EEG and ECG biomarkers to support psychiatric treatment decisions: • A web interface for hospitals and clinics to upload and store patien
Accepted 2 answers

Yes, your software would be considered Software as a Medical Device (SaMD) under the MDR. Even if you are not placing the software itself on the marke