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Showing posts tagged with: Technical File

The Ultimate Content List of Technical File for CE marking

The Ultimate Content List of Technical File for CE marking

You, as a medical device manufacturer, are responsible for gathering certain key information about your device for the CE mark. When we say key information, we mean technical documentation. All those documents you have to have it in one place, organized, before providing the final EU Declaration of Conformity. A soon as you put together and...
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8 things to know about CE approval process for Medical Devices

8 things to know about CE approval process for Medical Devices

As a medical device manufacturer which wants to place its product on the European market, you must be aware of all requirements to do so. Of course, one of the first things, you need to comply with Europe’s Medical Device Regulation (MDR). There are few ways to do so, and it’s known as conformity assessment routes. We...
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Weekly Cup of Joe 30# – DHFs & CE Technicals with Traceability Matrix

Weekly Cup of Joe 30# – DHFs & CE Technicals with Traceability Matrix

An effective traceability process is an essential requirement when developing medical device software and achieving regulatory compliance. How to create a Traceability Matrix? Traceability Matrix can be very difficult to create. It can take months to put together manually, especially without a proper tool. Creating and maintaining a TM can be time-consuming and difficult, not to mention all...
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