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  • I, too, am interested in everyone's opinion.  Does this book provide sufficient guidance on IVDs.  It seems like many documents and training for the new EU regulations really skimp or almost outright ignore the IVD side of medical devices.  Does this book warrant its price for IVDs? ------------------------------ Joy Pelfrey Director of RA/QA Norman ...

  • For the reasons you cite, I don't recommend citing the standard in a QS document unless there is a very specific reference. This avoids the problem of not know what version is implemented and the non-value maintenance of updating referenced standard when there are no references to the standard in the body of the procedure. Instead, develop the QMS ...

  • Hello Ryan,  I have used BSI and had the RoHS information in the technical file when it got submitted for review. If you do not have that currently, I would draft a letter detailing your current status for the NB and provide assurance on completion. They may accept the file for initial review. ------------------------------ Eric Bannon Newburyport ...

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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