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    ISO 13485 :2016

    Hi , Does anybody have an idea on : 4.2.3 Medical Device File : Assume this refers to the Device Master Record requirements (FDA terminology) and not the Technical file as required for CE marking. 7.3.7 Design development and validation and Clinical evaluation requirement - what exactly is the requirement here , does it refer ...

  • This appears to be one of the products that are not "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease" but fit the definition because they are "intended to affect the structure or any function of the body." The FDA will grant the De novo petition if the company provides ...

  • Hi Viky, In our firm, the incoming report of quality event is first evaluated and investigated under the complaint handling system.  This is primarily focused on understanding the issue, and can trigger corrective action.   If the device involves requires material disposition (e.g. rework  or replacement), that is handled under an NCMR that is linked ...

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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