Budgeting the EU MDR implementation

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):

• ISO 13485:2016 documentation toolkit https://advisera.com/13485academy/iso-13485-documentation-toolkit/
• ISO 13485:2016 & MDR Integrated Documentation toolkit - https://advisera.com/13485academy/iso-13485-eu-mdr-documentation-toolkit/

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