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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 recertification upon full completion.
Overview:
A management system, by definition, is a process by which a function or…
ContinueAdded by John Robinson on February 15, 2017 at 6:24am — No Comments
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…
ContinueAdded by John Robinson on February 13, 2017 at 7:29am — No Comments
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 FDA regulatory 510(k) clearance.
What makes preparing premarket…
ContinueAdded by John Robinson on February 10, 2017 at 4:19am — No Comments
Added by John Robinson on February 7, 2017 at 6:23am — No Comments
Overview:
Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with…
ContinueAdded by John Robinson on February 1, 2017 at 4:55am — No Comments
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