Day

July 6, 2015
The CWE can be a useful reference to use when performing medical device software risk management and security vulnerability analysis. The Common Weakness Enumeration Specification (CWE) provides a common language of discourse for discussing, finding and dealing with the causes of software security vulnerabilities as they are found in code, design, or system architecture. Each...
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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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