Therefore the whole team today is extremely pleased to have received EN ISO 13485:2016 from the Notified Body SQS. This will enable Bucher Leichtbau to develop new medical devices for use in the field of air rescue and, if necessary, to certify them.
“We are now able to approve our products efficiently and with the accustomed reliability at a European or even worldwide level. Due to our experience we were able to bring our processes up to the standard of EN ISO 13485:2016 in very short period of time which proves a high level of professionalism. This enables us to even better meet customer requirements and to continue to ensure patient safety,” says Beat Burlet, CEO of Bucher Leichtbau AG.
