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Budgeting the EU MDR implementation

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Guest user Created:   Mar 15, 2021 Last commented:   Mar 17, 2021

Budgeting the EU MDR implementation

To start with one large hospital, MDR Dept only, 28 staff in processing, what should we budget?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Mar 17, 2021

Let me see if I understand your question properly. You are asking what is the budget for the implementation of the ISO 13485 and Medical device regulation 2017/745 in your department. Considering the ISO 134b5, we can only state the approximate costs of the documentation toolkit. We do not know the prices of the notified bodies, especially now when the prices with MDR are much higher.

So, on the following link you can see what Documentation toolkit packages we are offering and what each package contains (how much time with the consultant in 1 & 1 meeting, how many e-mails, and how many documents we can review):

At the end of each page, under the title NEED MORE SUPPORT? you will see the packages.

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Mar 15, 2021

Mar 17, 2021