Outsource your post-market activities conveniently
Do the legal requirements after placing a medical device on the market occasionally cause you headaches, or is the effort required to implement them becoming increasingly unmanageable?
Our post-market solutions offer a remedy. We take over the monitoring and expert-supported evaluation of all publicly available information within the scope of the legally required post-market activities.
High reliability and low costs through 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.
Post-Market Radar
Ensure your regulatory approval and, above all, patient safety
The Post-Market Radar relieves you of the search for information relevant to your products and helps you to find all decisive notifications continuously. The outputs are then evaluated by our experts and supplemented by recommendations for action. At regular intervals chosen by you, you will receive a product-specific report that informs you about known and new risks of your products and gives you advice on what to do now.
Regulatory Radar
Never miss any important changes and new regulations
Instead of searching for, reading and evaluating regulations yourself, this update service informs you proactively. At regular intervals, you will receive a report with the regulatory changes and new regulations that are relevant for you, a summary explanation of the contents, and corresponding recommendations for action from our experts.
Strong synergies – The Post-Market and Regulatory Radar in combination
17
databases, including safety, literature, IT security, and clinical investigation databases are automatically searched.
3000+
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.
| Post-Market + Regulatory Radar | Market Comparison |
|---|---|
| All current information is provided in one tool. | You need multiple stand-alone solutions that do not cover all relevant information. |
| All databases relevant to you are continuously searched. | Only limited databases are searched. |
| The information is filtered and displayed according to product and manufacturer. | The information is not filtered by product and manufacturer. |
| All outputs are manually verified by our experts. | The outputs are not comprehensively verified. |
| All outputs are pre-assessed by our experts, and you receive a next-step recommendation. | The outputs are not pre-assessed by experts. You do not receive a recommendation. |
| Our experts support you in the creation of regulatory-compliant processes and documents. | There is no further support. |
Our team provides continuous support
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.
Contact us to book a free, non-binding demo to get a concrete picture of our post-market solutions and address your individual 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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