We are proud to announce that we are now ISO13485:2016 certified by SGS for the design, development, manufacturing and distribution of control systems, accessories and mounting systems for powered wheelchairs.
Over the past two years, we have received so many questions about the Medical Device Regulations 2017/745 (MDR). Some see this norm as an unwelcome burden that slows down innovation. And that may be partly true, but it also holds a commitment to high quality, safe products.That is why we have decided to embrace these regulations.
Compliance with ISO 13485 is often seen as the first and most important step in achieving compliance with the MDR. And it's certainly not the only step we have taken. We have also closed several combination agreements with wheelchair manufacturers, to help our customers to comply with the MDR demands and we will continue to do so in 2022.
To achieve our ISO certification, we had to show that we can provide medical devices and related services that consistently meet customer and applicable regulatory requirements throughout the entire life-cycle of the device (from design and development to distribution).
We are so proud of our team for achieving this milestone! Achieving this with a small team of 9 people is not an easy thing. But it proves our passion and our commitment to ensuring quality products and service to you - our customers.
Certificate number BE21/819944405, issued 14/01/2022