Behind the scenes: quality policy
It goes without saying that all SilverFit systems must be safe and function properly. The SilverFit 3D, the SilverFit Mile with a bike or with a treadmill, the SilverFit Rephagia and the SilverFit Newton, have all obtained the CE marking for medical devices Class I. All the other systems we offer also meet high quality criteria. For this purpose, SilverFit has a special team which keeps an eye on the quality of our systems and improves them.
The quality team
Aurin Hogers, biomedical scientist and quality specialist, is leading the quality team. She makes sure that all our products and business processes do not only comply with high-quality norms, but also meet all the legislative criteria. That most certainly applies to the medical devices with CE marking, which have to comply with strict European legislation. She works together with a beta tester and health professionals, such as physiotherapists specialized in geriatrics and speech therapists. Together, they ensure our systems’ compliance.
Based on scientific research
“There are quite a lot of things we have to check before a SilverFit system is ready to be installed in a care center” says Aurin. “The games and activities in all SilverFit systems are based on scientific research.” That also goes for something as simple as the virtual aquarium in the SilverFit Alois, which you can watch on the screen. Scientific studies have shown that older people eat better when there is an aquarium in the room.
Aurin: “The purpose of each system must be explicitly specified. This will determine which class a product belongs to. These categories decide on the requirements that the product has to meet. Using standardized tests, our tester then checks if the systems also comply with these norms. All bugs must be written down in a report. We have to keep track of every bug reported by our clients. This allows us to look back if something goes wrong.
In addition, we carry out an extensive risk analysis and take away as many risks as possible. Safety is always a priority: better safe than sorry. Luckily, until now we’ve only had small bug reports, which we could fix immediately.”
Quality further improved
“There is no legal obligation for complying with the ISO quality system. Yet we do work on our systems in order to obtain the certification ISO-13485, because we find it important that our clients can benefit from the best quality. That is why we work together with researchers, who study our systems’ effectivity. This allows us to keep improving the quality of our products.”
Would you like to know more about the advantages you benefit from, as one of our clients? Or would you like to experience the SilverFit systems yourself? Do not hesitate to contact us. We offer free demonstrations.