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  • I have a little bit different perspective. I think your software is stand-alone (software-as-medical-device), and the computer is an accessory. The reason is  that the software is not embedded, it's simply installed onto the commercial system, which adds new functionality but the computer still for the most part retains its functionality. The hardware ...

  • Hi Kevin, I have the same question for a product that I am working on. I will be very interested to see the responses. Sincerely , John Beasley, RAC (US) Founding Member and Senior Consultant MedTech Review, LLC www.medtechreview.com www.linkedin.com/in/medtechreview 257 Garnet Garden Street Henderson, ...

  • With respect to the FDA-regulated jurisdiction, power cords that have their own part number and label, and are used over and over and are only wiped down when needed, would not need to be direct marked for UDI.  Rationale/background provided below: As you allude to, FDA's UDI regulations require that devices intended to be reused and reprocessed before ...

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Rainer Voelksen, FRAPS, Talks Volunteering and European Advisory Committee

"Regulatory professionals need to hear the voices of those working in other countries. Just helping others to get used to hearing other languages is important, and you can be a cultural representative at the table in any stage of your career. The regulatory industry is increasingly global, but all regulators work differently. We must all work harder to become comfortable sharing information in an international space so that the industry can successfully continue to develop."

Rainer Voelksen, FRAPS


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