FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection. The trends and reports are showing that the FDA inspectors are focusing on electronic signatures and electronic records as more and more companies are implementing systems and technologies to […]
Because the current Directive will be significantly altered and replaced by a Regulation which is legally binding on all Member States.
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Design History File (DHF), Technical File and Design Dossier are important regulatory documents for a medical device. Design Control and Design History File are regulatory documents for medical devices in the FDA, while the Technical File and Design Dossier serve the same purpose for the EU’s regulatory body, the MDD. The Design History File The […]
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 […]
One of the important points that a medical device professional encounters is this: the technical file vs design dossier. The reason for the confusion about these two is that there are different names of the same concept and vary according to the class of device and the Notified Body that approves it. This is what […]