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BUNDLE Premium Pack – EU MDR Technical File

Original price was: 490,00€.Current price is: 345,00€.

This is the PREMIUM PACK for the EU MDR 2017/745. This pack contains instructions on how to create full technical documentation with the Structure. The full structure is already ready within the ZIP file. You just need to complete it with your own reports or documents. The templates available on the pack are already placed in the right folder within the appendixes.  In case you have already your own templates available, you just need to remove the ones on the folder and place your document.

The structure proposed can be changed per your Notified Body recommendations. Don’t hesitate to consult with Easy Medical Device if you have any questions.

Check the full content in the description below.

NOTA: There is no reimbursement for purchased documents.

SKU: EMD-TF-003 Category:

This EU MDR PREMIUM PACK contains most of the documents required by EU MDR. This means that you should purchase this pack if you need also all the additional templates. Otherwise, you need only to purchase the BUNDLE TECH FILE for MDR 2017/745

This PREMIM PACK contains the following documents

Documents presented individually

The documents presented below are independent of the product classification. But some of the documents are not necessary for example if your product is not a class III or Implantable like the SSCP.

We tried to give you as much guidance on the document as possible. But you may need the support of a consultant to fill up some of these documents.

Let us know if Easy Medical Device can help you.

Content of the pack

Below I provide you with a screenshot of each of the documents available.  The principal document is the Technical File and for all the annexes I tried to place a document to help you.

These documents may not be specific to your product so you should adapt them. Some documents are specific to a class I like the PMS Report. For other classes this is called PSUR.

For Class III and Implantable you should normally have an SSCP. So if your product is within another class then this is not a document you should us.

So even if you have this pack, you still need to assess which elements are needed or not.

In the case this is too complex for you, Easy Medical Device can help you create your Technical File as we have done that successfully for multiple companies.

How to use this pack and create your technical file

Technical File template

Classification route

Clinical Development

Clinical Evaluation

Declaration of Conformity

Risk Management

GSPR

Master IFU

IFU Checklist

Label Checklist

UDI Checklist

PMCF Templates

PMS Templates

SSCP

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