Quality management system at the heart of medical marking
Het is niet zomaar een product dat we op de markt brengen
Souraya Verhaegen, QA/RA Manager
Souraya Verhaegen is our QA/RA manager and responsible for the quality control and regulation of our viQtor solution. Together with our users, she has the most important voice in our organization, because if Souraya rejects an idea, the plan will not go ahead. That is how important the quality management system is in the development of a medical application. We have just completed an intensive process of medical certification (CE), in which our quality management system has been examined and assessed in detail. And approved! Thanks to Souraya's direction and the efforts of all of us, our viQtor is medically (CE) marked. And so: ready for the European market.
Quality sacred
“As a quality manager, I am a kind of grindstone for the development of our application. I consider that a great honor. It is also very nice that so much value is attached to quality within the club. Startups are known for going for short cuts in their ambition and almost every now and then. That is definitely not the case with us. The quality of our application is truly sacred. Every development is subject to strict quality controls.”
Medical product
“That is what makes my position as quality controller so special. If new plans don't meet our protocols, they can't go ahead. Or we have to draw up new protocols and have them certified. Given the medical nature of our product, this goes a long way. After all, we don't just make a product, our viQtor will play an important role in the care of frail elderly and patients. To guarantee its operation, you must set up a quality system in which you document every facet in the development. You can't even change supplier without recording that and checking whether the product and the supplier comply with European regulations."
24-hour patient monitoring
Due to the medical marking, the data from our 24-hour monitoring solution can now be used directly in healthcare. Continuous measurements of heart rate, oxygen saturation, skin temperature, motion, fall detection and location determination can then be used for diagnosis determination, trend analysis and remote incident reporting. The combination of medical device, portal and app makes viQtor extremely suitable for online following patients who are rehabilitating at home and frail elderly who live independently. This makes it possible to organize care for patients and clients more efficiently and effectively.
Make an appointment for a demonstration
Would you like to know more about viQtor, our solution for 24-hour monitoring? Make an appointment for a demonstration and discover what viQtor can do for you.
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Towards information security certification
Information security is of paramount importance to smartQare. We want to be sure that all data within our company cannot fall into the wrong hands. Laura Pomstra, together with our security officer, is now working on obtaining NEN7510 and ISO27001 certification for information security in healthcare.
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Student job at smartQare: developing viQtor and yourself!
Our team is constantly refining and developing the medical technology behind viQtor. In this process, we also receive support from students. For example, last year Frank Boon, Head of Research, could count on Simone de Jonge, a student at the Technical University in Eindhoven. She did the research for a new measurement within our 24/7 monitoring solution.
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The story of Fred Hoogeveen
Fred Hoogeveen (72) was always a real sportsman. He lived a healthy and active life. Until an accident turned his life upside down. Now he is paralyzed from the chest down. Yet he still gets the most out of his life every day.
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The next step: focus on clinical validation
Now that our viQtor has the CE mark, we are building the next step: conducting applied clinical studies in medical practice. This proves the added value of our solution for 24-hour monitoring compared to the current clinical standard. Jeroen Kortsmit is responsible for this process. As Clinical Science Manager, he focuses on setting up the clinical validation strategy.
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LUMC calibrates and validates oxygen saturation viQtor
The viQtor, our wearable for 24-hour monitoring, measures, among other things, the oxygen level in the blood. At the end of 2021, the LUMC, led by anesthesiologist Rutger van der Schrier, calibrated and validated the oxygen saturation measurements. With this, viQtor has taken an important step towards CE class IIa marking.
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A look behind the scenes at smartQare Operations
The viQtor solution is an ingenious interplay between the high-tech device that clients wear on the upper arm and a practical app for caregivers. Vital values are processed and communicated 24/7 in the background. We get a look behind the scenes in a conversation with our former COO, Paul Smilde.
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Let's meet: Henk Stapert, our new CTO
In the run-up to the market launch, we brought in former Philips healthcare innovation manager Henk Stapert PhD. As our new CTO, Stapert will focus on the technological path to the CE class IIB marking for medical devices based on the Medical Device Regulation (MDR) and the further development of our network care. Meet a driven innovator.
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Elderly care: Mrs. Janssen is more than a patient
A circle is not complete until you close it. That is my motto and the story of my life at the same time. But this story is mainly about Mrs. Janssen, a lady with a chronic condition that needs care.