Day

August 14, 2008
With the permission of Oliver Christ of PROSYSTEM AG in Hamburg, Germany, you can view or download slides at the link provided entitled: Cost-effective Application of Usability Engineering and Risk-Management. Oliver and his partner are heavily involved in standards and these slides provide an excellent overview of medical device usability, software, and risk management standards...
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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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