Stay compliant with our Regulatory Monitoring Solutions
Our cutting-edge artificial intelligence technology scans, analyzes, and interprets vast amounts of regulatory data, allowing us to provide you with the most accurate and up-to-date information relevant to your product portfolio of medical devices and pharmaceuticals.
Achieve reliable compliance and reduce costs with automation
Our automated solutions search all relevant data sources on a daily basis and monitor the most important regulations in the medical device and pharmaceutical sector - more than would be possible through manual search and review. The search results are compared and evaluated based on your product portfolio by intelligent algorithms, filtering out irrelevant information.
This not only increases compliance but also saves you the time-consuming, manual search effort and associated costs and minimizes the risk of incorrect search entries.
Regulatory Radar
Don't miss out on any important changes and new regulations
Instead of searching, reading, and evaluating regulations yourself, this update service proactively informs you. At regular intervals, you will receive a report from our experts with the regulatory changes and innovations that are relevant to you, a summary explanation of the content and corresponding recommendations for action.
Post-Market Radar
Don´t jeopardize your approval and patient safety
The Post-Market Radar relieves you of the search for the information relevant to your products and helps you to continuously find all the relevant messages. The results are then evaluated by our experts and supplemented by recommendations for action. You will receive a corresponding product-specific report at regular intervals of your choice, which informs you about known and new risks of your products and gives you advice on what you need to do now.
Strong synergies – The Post-Market and Regulatory Radar in combination
17
databases, including security, literature and IT security databases, as well as databases for clinical trials, are automatically searched.
5000+
medical device and pharmaceutical regulations from over 100 countries, including DINs, ENs, ISOs, FDA Acts and guidance documents, are monitored.
All
main markets are covered. This includes Europe, the United States, Brazil, Canada, China, and Japan.
50
experts from the Johner Institute are involved in the evaluation of the search results.
| Post-Market + Regulatory Radar | market comparison |
|---|---|
| All up-to-date information is provided in one tool. | You need multiple stand-alone solutions that don't cover all relevant information. |
| All databases relevant to you are searched continuously. | Only limited databases are searched. |
| The information is filtered and displayed on a product- and manufacturer-specific basis. | The information is not filtered on a product- and manufacturer-specific basis. |
| All results are manually verified by our experts. | The results are not fully verified. |
| All results will be pre-evaluated by our experts and you will receive a next-step recommendation. | The results are not pre-evaluated by experts. You won't get a recommendation. |
| Our experts support you in the creation of regulatory-compliant processes and documents. | There will be no further support. |
Click on the button to schedule a free, no-commitment demo that showcases the potential of our Regulatory Monitoring Solutions and provides answers to all your questions.
Do you have any questions?
- Cochrane Library - literature database with systematic reviews of medical publications
- Google Scholar - literature search of scientific documents
- Pubmed - literature database on medical publications
Safety databases
- ANVISA - Safety alerts and recalls Brazil
- BASG - Safety alerts Austria
- BfArM - Measures taken by manufacturers of medical devices in Germany
- FDA MAUDE - FDA database on Manufacturer and User Facility Device Experience
- FDA Recall - FDA database on medical device recalls
- HealthCanada - Recalls and safety alerts Canada
- MDD - Medical Device Division, safety alerts Hong Kong
- MHRA - Alerts and recalls for drugs and medical devices United Kingdom
- SARA - System for Australian Recall Actions; recalls Australia
- SwissMedic - Swissmedic monitors all safety measures of medical devices in Switzerland
- TPLC - Total product life cycle, Premarket and Postmarket data about medical devices (FDA)
IT security databases
- CERT - IT security database (Computer Emergency Response Team) of the federal administration
- NIST - IT security database of the National Institute of Standards and Technologies
Clinical investigation database
- CT-Gov - clinical investigation registry
If you have any further questions or concerns, please get in touch with us. We are looking forward to your inquiry!
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