The medical device technical file consists of a number of important files that supply thorough information regarding the device and its compliance with regulatory specifications.
Essentially each individual technical file ought to consist of a replica in the person instructions, the markings over the item and packaging and some other relevant details with the user.
Medical device technical files exhibit to regulatory authorities that a medical device complies with all applicable regulatory necessities.
A perfectly-structured medical device technical file is critical for guaranteeing the security and success within your products.
The look and manufacturing information and facts doc includes information about the device’s layout history, production processes, and products utilized. The security and efficiency prerequisites doc outlines the device’s compliance with applicable specifications and restrictions, and also the solution verification and validation details document is made up of exam studies and scientific investigation data.
This text handles just what the medical device technical file is, its worth when it is necessary, applicable specifications, written content, illustrations, And exactly how it really is reviewed. We also discuss the purpose of QMS computer software in controlling the medical device’s technical documentation.
Course IIb medical devices (excluding the above mentioned) and Class II devices are evaluated according to representative devices from Each and every team.
The medical device regulation as well as the in-vitro device regulation medical device technical file demand a UDI for being assigned to all medical devices, apart from custom made-created or investigational devices. The UDI is surely an addition to, not a substitute for, the existing labelling needs for medical devices.
You can certainly produce a snapshot of each products’s recent technical documentation and share it with the appropriate regulatory authorities.
The medical device file is An important portion of your respective compliance documentation. The summary doc with links to all needed paperwork have to be very easy to navigate, normally up-to-date, and ready for inspection on need.
Medical device technical documentation is significant because it helps show that the medical device is safe and efficient for its intended use.
This checklist supplies a higher stage overview of what really should be A part of the the technical file for most products:
As Sam Shelley details out, builders employing dedicated eQMS platforms like Cognidox can carry out large documentation responsibilities such as this with relative relieve:
Evidence of compliance with requirements: Demonstration of how relevant harmonised or Intercontinental criteria are actually used.