Previous Next

Latest Discussions

  • Does anyone know the what FDA guidance document spells out how many test fatigue cycles a cardiac device must survive? ------------------------------ Karen Bannick MA, RAC, FRAPS Principal & Founder Bannick Consulting LLC karen@bannickconsulting.com ------------------------------

  • ​Hi Julie, I've been asked that question before by those wanting to read the requirements for a technical file or design dossier, the other term commonly used, before reviewing what I drafted. Both the MDD and MDR use "technical documentation", which is why the STED format stands for summary of technical documentation. They added the "E" because the ...

  • As per 21 CFR 211.180  Any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or, in the case of certain ...

    1 person recommends this.

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


Most Active Members