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Regulatory Affairs Expert – Chatbot

Navigating the maze of medical device regulations has never been easier, thanks to the Regulatory Affairs Expert Chatbot. Powered by the latest AI technology – ChatGPT-4, this groundbreaking tool is your 24/7 guide to the European regulatory landscape for medical and in-vitro diagnostic devices, providing instant, and evidence-backed responses to your inquiries with all the actual data related to EU Medical Device space.

Main features and advantages:

Specialized Knowledge: Our chatbot is specifically trained in the European medical device field and has in-depth knowledge of key regulations like EU MDR 2017/745, EU IVDR 2017/746, MDSAP, ISO 13485, and all the actual data from today. This sets it apart from standard ChatGPT, which has general knowledge and is limited by September 2021.

Evidence-Backed Responses: Unlike the standard ChatGPT, our chatbot provides resources with every response, allowing you to see the evidence of the information shared and reinforcing your understanding.

24/7 Availability: Our chatbot is always on and ready to assist, providing instant responses to your queries at any time of the day or night.

Regular Updates: We regularly update the chatbot’s knowledge base with the latest regulatory changes, ensuring you always have access to the most current information.

Time and Effort Savings: The specialized knowledge and immediate responses provided by our chatbot can save you significant time and effort compared to searching for information yourself or using a general-purpose chatbot like standard ChatGPT.


Standard Tracking

Being always up to date with new or updated standards can be very time-consuming. That is where our standard tracking tool can help you. The tool tracks all ISO, IEC, IEEE, and DIN standards which are related to medical or in-vitro diagnostic devices.

Main features and advantages:

Efficiency: Instead of manually checking various websites you have them all in one place.

How to use: You can view all the updates directly on the member page or download all updates via an Excel list and use them for your own specific needs.


Recalls and warning letters (USA, Canada, Australia, Brazil, Japan)

Being always up to date with the latest recalls and warnings are very time-consuming. That is where this tool can support your PMS activities.

Main features and advantages:

Efficiency: Instead of manually checking various websites you have them all in one place.


CFR 21 Part 11 tracking

CFR 21 part 11 getting updated quite often. Therefore we have created this tracking tool to help you to be always up to date.

Main features and advantages:

Efficiency: Instead of manually checking you have them all in one place.


Regulatory Intelligence Paper

Be always informed about upcoming rules, regulations, guidances and standards.

What you get:

You get from us an Intelligence Paper on a monthly basis with all the related regulatory updates related to all MDSAP countries + EU, UK, and Switzerland.


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Included are:

  • Get access to Chatbot – Regulatory Affairs Expert
  • Get access to Standard tracking
  • Recalls, safety and warning letters (USA, Australia, Canada, UK)
  • CFR 21 Part 11 tracking
  • Receive our Regulatory Intelligence Paper (with focus on all MDSAP countries)
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