IntroductionHandheld devices are light-weight and compact devices that can be operated holding it in your hands. Handheld medical devices are available for medical information, used by physicians,…Continue
Started this discussion. Last reply by Arnold Brame Aug 16, 2014.
Course "How to build a complete Safety, Health & Environment Management System through Standards & Practices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC…Continue
Posted on February 15, 2017 at 6:24am
The Design History File (DHF), the Technical File (TF) and the Design Dossier (DD) are core regulatory documents for a medical device. This is how one can understand the central difference between them: the Design History File (along with Design Control), is the most important among the regulatory documents that the FDA requires for medical devices, while the Technical File and Design Dossier are documents that serve the same purpose, however, within the EU’s regulatory…Continue
Posted on February 13, 2017 at 7:29am
Preparing premarket submissions that win regulatory approval is a complex task, even for the most seasoned professional in the medical devices industry. This is because of the highly stringent nature of the regulatory approval pathways, namely the Premarket Approval (PMA) process and…Continue
Posted on February 10, 2017 at 4:20am