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  • Dear Silambarasan, The priority here is to discuss the issue with your Notified Body. As a general advice, not all international standards are harmonized and the harmonization of many standards (e.g. in the IEC 60601-series) has been delayed by years for several reasons. However, the Essential Requirements of the Medical Device Directive (Annex ...

  • ​I'm not familiar with a Clinical Study Agreement.  Under which regulations is the trial to be conducted?  IDE? ------------------------------ Julie Omohundro, ex-RAC (US, GS), still an MBA Principal Consultant Class Three, LLC Durham, North Carolina, USA 919-544-3366 (T) 434-964-1614 (C) julie@class3devices.com ------------------------------

  • Thanks Mr. Edwin Bills and Mr. Dan O'Leary for the detailed answers. I am pretty much clear now. Thanks all   ------------------------------ Silambarasan Subramanian Senior Engineer - Quality & Regulatory Affairs Schiller Healthcare India ------------------------------

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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