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.

After having worked for 22 years as a quality manager at Philips, a large part of which at Philips Healthcare, Souraya Verhaegen chose smartQare. How did you experience that from a large concern to a small startup? Souraya: “I was looking for a new challenge and I definitely found it at smartQare. At a large company you are somewhat on your own island within the organization. And at smartQare we tackle everything together. If there is a problem, everyone thinks along and wants to contribute to the solution based on their own expertise. That driven team spirit has brought us where we are today, a unique product with a medical mark.”

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.