We just received our MDR IIa certificate for ACTIMI Signals. Our medical backend handles vital data, produces alerts, and sorts patients based on urgency. This marks the end of a two-year-long process. And the good news is: You can use ACTIMI Signals in your own solution.
What Is ACTIMI Signals?
ACTIMI Signals is an MDR IIa-certified, cloud-based software designed for vital parameter analysis. It can be implemented as an API in any third-party digital health solution.
As an example, if you have a digital health app with a Bluetooth-connected blood pressure device, you can use ACTIMI Signals to analyze the vital parameters and show alerts to doctors when the blood pressure is higher than defined by a doctor. You can use your own frontend and integrate ACTIMI Signals as an API into your solution. It then handles the data, and you can provide your application to doctors in a clinical setting.
With ACTIMI Signals, users like doctors can define limit values for specific health parameters, and based on the abnormality, it outputs alerts and sorts patients. The input of medical data should come from a certified medical device. ACTIMI Signals can handle the following vital parameters:
Symptoms
Blood pressure
Heart rate
Blood glucose
Blood oxygen levels
Body temperature
Body weight
We will add more vital parameters in the future. Let us know if your solution benefits from further parameters!
Why This Matters
With this certification, ACTIMI Signals now serves as a plug-and-play, certified solution for companies looking to provide vital sign monitoring, symptom tracking, and clinical alerts. This opens up new possibilities for the market to focus on building great products in the medical space with a certified foundation.
While MDR certification is necessary for ensuring quality standards, it is often seen as a bottleneck. We hope we can deliver true value to our partners, customers, patients, and doctors by providing a “Certified Medical Backend as a Service.”
When Do You Need an MDR IIa Certification?
If, for example, you have a digital health app that receives and shows vital parameters to doctors, your app needs to be MDR IIa certified in most cases on the European market. Also, showing alerts or sorting patients based on urgency falls under the scope of the MDR IIa certification.
Receiving MDR IIa certification is a long process that involves implementing a quality management (QM) system, documenting your development process, and having on-site and off-site audits. This process can take up to two years and costs several hundred thousand euros. For startups, this is a huge entry barrier. For established companies, this is also a significant burden when entering new market segments.
What Are the Use Cases For a MDR Certified Medical Backend?
There are many possible use cases in the European digital health space and many types of organizations that can benefit from a certified backend.
For Startups
Three years ago, we found ourselves deciding whether we wanted to start an MDR IIa certification for our Remote Patient Monitoring Platform, ACTIMI Telecare, or not. We decided to take this huge leap but were aware of the financial strain this would place on a young company. Now, we can support young companies that want to quickly start with an MVP in the medical space or want to evolve their solution—either by focusing on software, delivering features to patients and doctors, or developing a novel medical device. You can use ACTIMI Signals to enter the market quickly with certified vital parameter analysis.
For IoT and Medical Device Manufacturers
Complete your offering for medical professionals or patients in a medical setting with certified software. You can use your own app and dashboard, and our certified backend handles the certification part. Your device must be certified according to MDR IIa so that it can be sold for medical use cases.
For MedTech Companies and Lifestyle Apps
If you already provide a lifestyle solution to your users, you can now open your service to medical use cases. Especially if you already have vital parameter tracking with a rich feature set. Either provide patients with alerts based on their vital parameters or provide the data to medical professionals.
Part of a Larger Vision: Innovation Through Collaboration
This certification was achieved as part of the Actimi Signals-funded project, developed in collaboration with the Ministerium für Wissenschaft, Forschung und Kunst Baden-Württemberg.
We are happy that the result not only enables us to use our own apps and products as certified medical devices but also potentially gives the whole industry a chance to innovate with more freedom. This is the first time a … (sentence appears incomplete, please clarify).
Join Our Waiting List- Be Among the First to Access ACTIMI Signals!
ACTIMI is already integrating Signals into our own products, and we invite you to be among the first to leverage this technology for your own business.
Join our waiting list today and stay ahead in the evolving digital health landscape. Get access to our certified API, early integration support, and exclusive launch partner benefits.
We just received our MDR IIa certificate for ACTIMI Signals. Our medical backend handles vital data, produces alerts, and sorts patients based on urgency. This marks the end of a two-year-long process. And the good news is: You can use ACTIMI Signals in your own solution.
What Is ACTIMI Signals?
ACTIMI Signals is an MDR IIa-certified, cloud-based software designed for vital parameter analysis. It can be implemented as an API in any third-party digital health solution.
As an example, if you have a digital health app with a Bluetooth-connected blood pressure device, you can use ACTIMI Signals to analyze the vital parameters and show alerts to doctors when the blood pressure is higher than defined by a doctor. You can use your own frontend and integrate ACTIMI Signals as an API into your solution. It then handles the data, and you can provide your application to doctors in a clinical setting.
With ACTIMI Signals, users like doctors can define limit values for specific health parameters, and based on the abnormality, it outputs alerts and sorts patients. The input of medical data should come from a certified medical device. ACTIMI Signals can handle the following vital parameters:
Symptoms
Blood pressure
Heart rate
Blood glucose
Blood oxygen levels
Body temperature
Body weight
We will add more vital parameters in the future. Let us know if your solution benefits from further parameters!
Why This Matters
With this certification, ACTIMI Signals now serves as a plug-and-play, certified solution for companies looking to provide vital sign monitoring, symptom tracking, and clinical alerts. This opens up new possibilities for the market to focus on building great products in the medical space with a certified foundation.
While MDR certification is necessary for ensuring quality standards, it is often seen as a bottleneck. We hope we can deliver true value to our partners, customers, patients, and doctors by providing a “Certified Medical Backend as a Service.”
When Do You Need an MDR IIa Certification?
If, for example, you have a digital health app that receives and shows vital parameters to doctors, your app needs to be MDR IIa certified in most cases on the European market. Also, showing alerts or sorting patients based on urgency falls under the scope of the MDR IIa certification.
Receiving MDR IIa certification is a long process that involves implementing a quality management (QM) system, documenting your development process, and having on-site and off-site audits. This process can take up to two years and costs several hundred thousand euros. For startups, this is a huge entry barrier. For established companies, this is also a significant burden when entering new market segments.
What Are the Use Cases For a MDR Certified Medical Backend?
There are many possible use cases in the European digital health space and many types of organizations that can benefit from a certified backend.
For Startups
Three years ago, we found ourselves deciding whether we wanted to start an MDR IIa certification for our Remote Patient Monitoring Platform, ACTIMI Telecare, or not. We decided to take this huge leap but were aware of the financial strain this would place on a young company. Now, we can support young companies that want to quickly start with an MVP in the medical space or want to evolve their solution—either by focusing on software, delivering features to patients and doctors, or developing a novel medical device. You can use ACTIMI Signals to enter the market quickly with certified vital parameter analysis.
For IoT and Medical Device Manufacturers
Complete your offering for medical professionals or patients in a medical setting with certified software. You can use your own app and dashboard, and our certified backend handles the certification part. Your device must be certified according to MDR IIa so that it can be sold for medical use cases.
For MedTech Companies and Lifestyle Apps
If you already provide a lifestyle solution to your users, you can now open your service to medical use cases. Especially if you already have vital parameter tracking with a rich feature set. Either provide patients with alerts based on their vital parameters or provide the data to medical professionals.
Part of a Larger Vision: Innovation Through Collaboration
This certification was achieved as part of the Actimi Signals-funded project, developed in collaboration with the Ministerium für Wissenschaft, Forschung und Kunst Baden-Württemberg.
We are happy that the result not only enables us to use our own apps and products as certified medical devices but also potentially gives the whole industry a chance to innovate with more freedom. This is the first time a … (sentence appears incomplete, please clarify).
Join Our Waiting List- Be Among the First to Access ACTIMI Signals!
ACTIMI is already integrating Signals into our own products, and we invite you to be among the first to leverage this technology for your own business.
Join our waiting list today and stay ahead in the evolving digital health landscape. Get access to our certified API, early integration support, and exclusive launch partner benefits.
We just received our MDR IIa certificate for ACTIMI Signals. Our medical backend handles vital data, produces alerts, and sorts patients based on urgency. This marks the end of a two-year-long process. And the good news is: You can use ACTIMI Signals in your own solution.
What Is ACTIMI Signals?
ACTIMI Signals is an MDR IIa-certified, cloud-based software designed for vital parameter analysis. It can be implemented as an API in any third-party digital health solution.
As an example, if you have a digital health app with a Bluetooth-connected blood pressure device, you can use ACTIMI Signals to analyze the vital parameters and show alerts to doctors when the blood pressure is higher than defined by a doctor. You can use your own frontend and integrate ACTIMI Signals as an API into your solution. It then handles the data, and you can provide your application to doctors in a clinical setting.
With ACTIMI Signals, users like doctors can define limit values for specific health parameters, and based on the abnormality, it outputs alerts and sorts patients. The input of medical data should come from a certified medical device. ACTIMI Signals can handle the following vital parameters:
Symptoms
Blood pressure
Heart rate
Blood glucose
Blood oxygen levels
Body temperature
Body weight
We will add more vital parameters in the future. Let us know if your solution benefits from further parameters!
Why This Matters
With this certification, ACTIMI Signals now serves as a plug-and-play, certified solution for companies looking to provide vital sign monitoring, symptom tracking, and clinical alerts. This opens up new possibilities for the market to focus on building great products in the medical space with a certified foundation.
While MDR certification is necessary for ensuring quality standards, it is often seen as a bottleneck. We hope we can deliver true value to our partners, customers, patients, and doctors by providing a “Certified Medical Backend as a Service.”
When Do You Need an MDR IIa Certification?
If, for example, you have a digital health app that receives and shows vital parameters to doctors, your app needs to be MDR IIa certified in most cases on the European market. Also, showing alerts or sorting patients based on urgency falls under the scope of the MDR IIa certification.
Receiving MDR IIa certification is a long process that involves implementing a quality management (QM) system, documenting your development process, and having on-site and off-site audits. This process can take up to two years and costs several hundred thousand euros. For startups, this is a huge entry barrier. For established companies, this is also a significant burden when entering new market segments.
What Are the Use Cases For a MDR Certified Medical Backend?
There are many possible use cases in the European digital health space and many types of organizations that can benefit from a certified backend.
For Startups
Three years ago, we found ourselves deciding whether we wanted to start an MDR IIa certification for our Remote Patient Monitoring Platform, ACTIMI Telecare, or not. We decided to take this huge leap but were aware of the financial strain this would place on a young company. Now, we can support young companies that want to quickly start with an MVP in the medical space or want to evolve their solution—either by focusing on software, delivering features to patients and doctors, or developing a novel medical device. You can use ACTIMI Signals to enter the market quickly with certified vital parameter analysis.
For IoT and Medical Device Manufacturers
Complete your offering for medical professionals or patients in a medical setting with certified software. You can use your own app and dashboard, and our certified backend handles the certification part. Your device must be certified according to MDR IIa so that it can be sold for medical use cases.
For MedTech Companies and Lifestyle Apps
If you already provide a lifestyle solution to your users, you can now open your service to medical use cases. Especially if you already have vital parameter tracking with a rich feature set. Either provide patients with alerts based on their vital parameters or provide the data to medical professionals.
Part of a Larger Vision: Innovation Through Collaboration
This certification was achieved as part of the Actimi Signals-funded project, developed in collaboration with the Ministerium für Wissenschaft, Forschung und Kunst Baden-Württemberg.
We are happy that the result not only enables us to use our own apps and products as certified medical devices but also potentially gives the whole industry a chance to innovate with more freedom. This is the first time a … (sentence appears incomplete, please clarify).
Join Our Waiting List- Be Among the First to Access ACTIMI Signals!
ACTIMI is already integrating Signals into our own products, and we invite you to be among the first to leverage this technology for your own business.
Join our waiting list today and stay ahead in the evolving digital health landscape. Get access to our certified API, early integration support, and exclusive launch partner benefits.
Updated date:
Mar 19, 2025
