ISO 13485 certificate

BS&i Mechatronics has achieved ISO 13485: 2016 certification. And we are proud of that. The reason for this is that more and more companies are calling on us to assemble and test medical devices. This supports our clients to comply with MDR (EU) 2017/745.

Strong organization

To obtain the certificate, we have changed our organization and practices on several fronts and levels. This is all aimed at reducing risks in the broadest sense of the word and focused on the safety of users of medical devices.

In addition to the introduction of the ISO 13485 certificate, we already hold the ISO 9001 certificate and a well-functioning ERP system. This has resulted in a strong organization prepared for the future. With that, our motivated staff has all the tools to provide maximum service and satisfaction to our customers. See also our webpage “Customers tell“.

Our strong organization also gives us a great advantage in supporting our customers with non-medical devices. They benefit from the learning process we went through to optimize our performance.

Broad product portfolio

The increasing number of medical devices has led to a broadening of our product portfolio. Our high-quality organization has also increased interest among non-medical clients. Moreover, we see that our “modification” and “repair” services have also increased. Procurement of materials, components and parts has boomed this year. Apparently, our customers have discovered that this benefits them greatly.

Our strength

All in all, our strength to provide maximum service and satisfaction to our customer has increased. We do this on both, technical, logistical and organizational levels combined with a pleasant and personal way of working together. The thing that our customers regularly compliment us on.