MDR GAP Assessment

Service Description

Are you ready for the EU MDR? We support you to easily implement the new Medical Device Regulation 2017/745. What is a MDR Technical Documentation GAP Assessment? A MDR GAP Assessment is the process in which a medical device’s technical documentation is systematically examined to determine whether it demonstrates conformity with all relevant MDR 2017/745 requirements defined in Annex II and Annex III. How we can support you: We can help with your MDD to MDR transition! To keep track of the regulations, in-depth knowledge and reliable interpretation of the new regulations is essential. That’s where our expert steps in! With our guidance, your team will know precisely which areas need to be revised in accordance with the new MDR. What is included in the MDR Technical Documentation GAP Assessment? One of our experts reviews your existing Technical Documentation systematically against the requirements defined by Annex II & III of the MDR. You will get an evaluation about the completeness of your documents and we will point out missing or inconsistent items and potential gaps. (Note: The GAP Assessment contains a consistency review of all required documents. A deeper content review of complex documents like labeling, IFUs, clinical evaluation can be booked in addition to the MDR GAP Assessment. Let us know if you are interested.) Book the MDR GAP Assessment directly online (for 990€ including value-added tax) and our expert will be at your service. Check our consultation hours in the calender in the next step. However, they're not set in stone and we are more than happy to arrange another day and time according to your individual needs. Whatever suits you best! We are pleased to provide our services in English and German. Consult us in the language you feel most comfortable with. How to proceed? 1. Start the checkout process by clicking the 'Book Now'- button. 2. Continue the checkout process and add your personal info. 3. After completing payment, you'll receive the link to your online-meeting in a booking confirmation via Mail. 4. If everything's settled for you, there's nothing else to do and we're looking forward to our meeting. Otherwise don't hesitate to contact us and we're happy to rearrange another day and time according to your individual needs. Let us boost your EU MDR compliance!

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