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
17
databases, including safety, literature, IT security, and clinical investigation databases are automatically searched.
4000+
regulations from over 50 countries, including DINs, ENs, ISOs, FDA acts, and guidance documents are monitored.
All
major markets are covered. This includes Europe, the United States, Brazil, Canada, China, and Japan.
50
Johner Institute experts are involved in evaluating the search results.
| Our RI Solution | Other 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?
- 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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