Homecare improves the quality of care: Health problems are detected earlier when people are monitored at home. Preventive actions can be taken reducing hospitalization and improving quality of life. Mobile care also improves efficiency: When mHealth tools may be used for diagnosis and therapy, mobile devices can support doctors making their diagnosis wherever they are and mobile devices can facilitate treatments.
When a mobile device is used for diagnosis or therapy, it must meet the Medical Device Directive (MDD) or the Medical Device Regulations (MDR). The impact of a device on health is different when it is used to just measure or when it is used for diagnosis and therapy. The demands on the software also differ: Software in diagnosis or therapy devices must meet stricter rules than software in measuring devices. Specialists estimate that the creation of diagnosis or therapy software cost around 4x the effort of creating health measuring software.
The high development costs and expertise needed to create software for diagnosis and therapy are major barriers for manufacturers to advance in medical diagnosis and therapy tools. The INZENTIZ platform overcomes this barrier.
The INZENTIZ Mobile Medical Software Platform provides the software infrastructure for medical devices functionality involving mobile devices and cloud services. We provide a high-tech platform to simplify mobile care and improve patient experience in a safe and compliant environment. Using the INZENTIZ platform means you have less work, less costs and a fast market release for your mobile medical application.
Much more than a Secure Cloud
The Inzentiz Platform is much more than a “Secure Cloud”. The platform delivers the infrastructural framework for the application: data acquisition, secure local storage, encryption, a presentation framework, filter agents, alarms and warnings, infrastructure for the domain analyses and infrastructure to send and retrieve data to/from the Cloud.
Applicable on all mobile devices
It further delivers the infrastructural framework for the Dashboard PCs (PCs and mobile devices) at hospitals or other caretakers (for example private clinics, therapist or homecare). All functionality that is domain independent and common in mobile applications is facilitated by the platform.
Everything you need in a medical device
The Platform takes care of typical MDD/MDR functionality like roles and access management, reacting to device determined events and handling everything else that is typically needed in a mobile medical device. The manufacturer of the medical device can use Application Programming interface (API) calls to invoke all functions in the domain part.
Frees you of more than 60% of the work and costs
The INZENTIZ Mobile Medical Software Platform covers a huge part of the software code and covers more than 60% of the product’s traceability matrix, leaving only one third of the total work to the manufacturer. For example the domain code and related tests.
Ready to use and future proof
A measuring application to measure data now, may in the future be used for diagnosis and therapy. The INZENTIZ Platform will meet the regulations for all medical software classes (class I, II and III), thus securing your investment for the future.
You can realize a fast market release
Since the use of the Platform also reduces the development time with at least 60%, the market release can be much faster. The INZENTIZ Platform will - in due time - meet both FDA and CE regulations. You can therefore release your application on the world market. Read more
The INZENTIZ Platform will cover approximately 80% of the software code, and therefore more than 60% of the product’s traceability matrix, leaving only one third of the total work to the manufacturer: the domain code and related tests.
The INZENTIZ Platform will provide the general software contained in any CE/FDA mobile application. For example the secure data-transport, -storage, -encryption and messaging. The common functionality accounts for about 80% of the software of mobile applications.
The work left for the manufacturer is the development of the domain part of the product which consists of around 20% of the total code. This results from domain requirements (functional and non-functional). Many of which will be gathered in a usability study with users. Creating the domain part not only demands knowledge of the domain, it also requires knowledge of CE/FDA regulations. To support the manufacturer with the latter, Inzentiz works together with the best QA/RA- and Usability consultants who will guide the development of the domain part.
Developing the domain part of an medical device application still demands MDD expertise. The domain code needs to meet medical device demands as well but the needed MDD expertise is mainly available in the medical device industry.
INZENTIZ partners provide you with the needed support and expertise in the area of Quality & Regulatory services, mobile software development, usability design and conformity tooling to create and maintain your mobile medical device file. INZENTIZ intends to organize regular user meetings.
Our prices make it possible for start-ups to quickly develop high-tech medical solutions. To lower the CE/FDA threshold for manufacturers of mobile medical devices and applications, we restrict the license price and ask a fair contribution for the INZENTIZ Cloud services.
Service contracts are mandatory since we will provide manufacturers with eventually regulatory-wise mandatory upgrades. All updates and upgrades are part of the service contract and will be received free of charge. The payment of the Cloud services are based on the actual services used.
A measuring application that uses our platform to measure medical data now, may in the future be used for diagnosis and therapy as well. The INZENTIZ Platform will meet regulations for the highest and thus all medical software classes (class I, II and III) thus securing your investment for the future.
The INZENTIZ Platform will become an IEC60601, Annex 9 Accessory consisting of code and MDD/MDR file (Requirements, Risk Analysis, Traceability matrix, Design History File etcetera). The Framework will become suitable for Class III products and all software code will meet IEC62304 class C.
The INZENTIZ Platform will include a secure and scalable Cloud environment, it will adhere to ISO 27001 and ISAE3000 standard and will continue to work without internet access. The Cloud authorization can be configured using roles and domain specific permissions.
Healthcare can only become homecare with CE certification or FDA approval:
This table shows the essential differences between normal mHealth applications and medically certified (CE/FDA) mHealth apps. As you see: it is not about details but about the essence of healthcare @ home: becoming or not becoming reality!
Non-certified mHealth Apps
CE-certified and FDA approved Apps
Self-measurements for patients (monitor body parameters)
Workflow improvements for processes (like video-consults)
Improvement of lifestyle, fitness and clinical workflows
Clinical effectiveness: how to prove this?
Reliability of findings: how to prove them?
Quality of the App: how to show this?
HIPAA compliancy to prove security & privacy
Quality mark for non-certified Apps (EU initiatives are available)
Challenges for healthcare
False negatives: the problem isn’t detected
False positives: there wasn’t a problem
Double work: Doctor needs to repeat measurements with certified devices… But will it show-up again?
Challenges for the manufacturer
Becoming used by care professionals (prohibited for liability reasons)
Adding (enough) value to the care process
Finding reimbursement partners
Fitting in the existing healthcare reimbursement scheme
Being recognized between all apps on the market
Receiving wide acceptance by care professionals (combined reasons)
Measuring body parameters related to diseases
Improvement of the quality and effectiveness of healthcare
Moving healthcare to healthcare @ home
Improving patient monitoring, care, cure and workflow of care
Early detection of problems with patients’ health
Preventing co-morbidity and/or accidents
Clinical effectiveness: part of CE/FDA certification process!
Reliability of findings: part of CE/FDA certification process!
Quality of the App: guaranteed by CE/FDA certification!
CE and FDA is existing legislation for medical devices in EU and USA
HIPAA compliancy -security & privacy- are guaranteed
Wins for healthcare
Improved quality of patient care and healthcare
Reduction of costs for better healthcare
High added value for both healthcare and patients
For the manufacturer
Due to high added value, the earning model will be easy to find
Apps comply with legislation and will fit in the reimbursement system
Learning how a CE/FDA certification is realized
Find funding to finance the CE/FDA certification
The INZENTIZ Mobile Medical Software Platform will meet all demanded or relevant standards needed for a CE and FDA Class III application.
Who we are
Who we are
Inzentiz was founded in 2014 by four entrepreneurs who are convinced that a mobile medical software framework will help manufacturers to realize mobile medical applications substantially faster. These applications are able to measure and provide support in diagnosis and therapy.
Every day, we seek to provide secure, collaborative and patient centered mobile health solutions with a unique combination of mobile IT development excellence, medical and regulatory expertise and certified quality-orientated development processes.
The team has Medical Device Directive (MDD) software development experience in more than 15 medical applications and in various medical fields. Our track-record and excellence in performance is confirmed by specialists from the MDD field. Some of the companies the team have worked for include: Philips, Demcon, Unitron, Nucletron/Elekta and we've created solutions for hospitals like UMC Utrecht, St Antonius Hospital, Gelre Hospital and Ter Gooi Hospital. We leverage this experience to create the Inzentiz® platform.
We are driven by excellence. In everything we do, we behave ethically and strive to attain the highest level of quality. Always working to enhance our processes by continuous improvement. Our development methodologies embed among others the IEC 62304-C and IEC 62366 standards.
- IJsselburcht 3,
6825 BS Arnhem
My Vision is that man will become healthier when healthcare improves. My Mission is to support (young) mHealth and medical device companies to achieve their goals. Keywords: interested in new methods and technologies to push the borders of what is possible and explore new frontiers together with our customers.
Derk van Wijk
Being in the first place an entrepreneur I have had the opportunity of working in different fields and several (international) companies, becoming familiar with ICT, (sustainable) energy, waste collection & recycling as well as Telecom. As a partner at Inzentiz, where I’ll be responsible for business development, I’m driven by my belief that healthcare can and should innovate and improve itself. I’m looking forward to teaming up with the Inzentiz people, the company, being part of the major changes the Inzentiz CE-platform will make in the coming years.
After finishing my education I directly started in the field of Medical Software Development. In the context of my own company I held various technical roles in all sorts of projects, among which software architect and team lead. While always being focused on the quality I'm also keen to get the product finished. Having worked on medical devices, hospital systems, information systems and connectivity products makes Inzentiz seem the next logical step.
Having a great time with the challenges of making a medical platform so that you don't have to. I'm a go-getter who is always eager to learn. My goal is to give medical apps the quality that patients deserve using my experience as software developer and team leader on creating software for medical devices.
I'm an avid software enthousiast and have been developing medical device software for the past 10 years from my own company. My role in most projects is firmly on the technical side of things but I'm also often focussed on quality and regulations. When it comes to software I want it be simple, elegant and clear with safety embedded in the design.
Drs. Peter Ruys is an expert consultant in International Medical Device regulations. Peter has degrees in physics and chemistry. As clinical physicist he has fulfilled various roles in a University Hospital in Amsterdam during 20 year. In 1991 he was invited to set up the notified body KEMA (now DEKRA). Afterwards he was consultant including executive director of Qserve and non-executive director of Obelis in Brussels. He has lectured at several seminars across the world. Peter is still active in the standardization working group for clinical evaluation at NEN.
Inzentiz receives financial support from the European Fund for Regional Development in the context of the operational programme Oost-Nederland 2014-2020.
We use this aid is to realize the Inzentiz medical platform. This supports disruptive innovation in the medical field and improves medical care.