Stay Compliant with AI-Powered Regulatory Intelligence

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.

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 - more than possible through a manual search and review. The search results are matched and evaluated against your product portfolio by intelligent algorithms, filtering out information that is not relevant.

This increases compliance, saves time-consuming manual searches and related costs, and minimizes the risk of incorrect search entries.

Receive Personalized Regulatory Updates Tailored to Your Needs

Tailor your regulatory alerts and notifications based on your specific products, markets, and compliance requirements. Our platform ensures that you receive only the information that matters to your business, saving you time and effort.


Gain Full Control Over Your Compliance Status with Our Comprehensive Dashboard

Gain a holistic view of your regulatory landscape with our intuitive dashboard. Monitor regulatory changes, track compliance progress, and access valuable insights to make informed decisions and stay ahead in the rapidly evolving medical device industry.

Optimize Your Regulatory Processes with AI-Driven Insights


databases, including safety, literature, IT security, and clinical investigation databases are automatically searched.


regulations from over 50 countries, including DINs, ENs, ISOs, FDA acts, and guidance documents are monitored. 


major markets are covered. This includes Europe, the United States, Brazil, Canada, China, and Japan. 


Johner Institute experts are involved in evaluating the search results.

Our RI SolutionOther Solutions
All the current information you need is provided in a single, comprehensive tool.You may need to navigate multiple standalone tools, which might not cover all relevant information.
Our solution continuously searches all databases relevant to you.Other solutions might search only a limited number of databases.
We filter and present information specific to your product portfolio.The information in other solutions may not be filtered by products.
All outputs are manually verified by our experts for accuracy and relevance.The outputs from other solutions might not be comprehensively verified.
Every output is pre-assessed by our experts, providing you with actionable next-step recommendations.Other solutions might not offer pre-assessment by experts or provide recommendations.
Our team assists you in creating regulatory-compliant processes and documents.You might not receive further support with other solutions.

Benefit from Our Expert Support and Guidance

You also benefit from additional consulting and other services provided by our experienced experts. These include, for example, product analysis to coordinate the PMS search strategy, research and creation of the list of applicable regulations, process reviews, and the provision of templates.


Get in touch with us to schedule a free, no-commitment demo that showcases the potential of our RI solutions and provides answers to all your questions.

Do you have any questions?

Perhaps these FAQs will help you:

Yes, our RI solution uses advanced artificial intelligence algorithms to analyze and break down complex regulatory data, turning it into straightforward and actionable insights.
Our RI solution provides real-time updates, helping you stay on top of regulatory changes and ensuring your business remains compliant at all times.
Indeed, our RI solution provides access to a comprehensive database that includes global regulatory bodies and their corresponding regulations, offerin a holistic view of your compliance landscape.
Absolutely, you can tailor your notification settings to receive personalized alerts on regulatory changes that directly impact your business.
Our RI solution comes with an intuitive, easy-to-navigate dashboard that simplifies the task of sifting through complex regulatory data to gain meaningful insights.
Yes, the RI solution includes features that enhance collaboration, such as shared access, task assignments, and shared notes.
Certainly, the RI solution includes predictive analysis features that can spotlight regulatory trends, supporting your forward planning and strategic decision-making.
Yes, our RI solution can be seamlessly integrated with your existing systems, creating a unified and efficient compliance management process.
We offer comprehensive training and ongoing support to ensure you get the most out of our RI solution. Our goal is to ensure your team feels comfortable and confident in leveraging our tool to its full potential.
Currently, our solution extends to all major markets, encompassing approximately 60 countries, and we are consistently broadening our reach.
While our core expertise lies in serving the life sciences industry, particularly MedTech and Pharma, our reach extends beyond these areas to include sectors such as environmental regulation. Our solution's versatility ensures that it can be seamlessly adapted to cater to an even wider range of industries.
Literature databases
  • 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
The pricing for our post-market solution varies and is tailored to your specific needs, rather than being a standard flat rate. Factors that influence the cost include the number of databases to be queried, the volume of regulations to be monitored, and the frequency of required reports throughout the year.

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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