Aidee receives ISO 13485 certification
Following a two year implementation process, Aidee finally receives its ISO-13485 certification from BSI. This is a very important milestone in getting our first certified medical device in the market.
A long but learningful implementation process has come to an end as Aidee finally receives its ISO-13485 certificate from BSI. The certificate verifies that Aidee has a Quality Management System for Medical Devices complying to the ISO-13485:2016 standard.
We're very pleased to receive the ISO-13485 certification, as it proves that our procedures and processes are in-line with best practices in the medical device field. Not to mention the fact that the certification is an important step along the way to CE-marking of our upcoming product and can be considered a license to operate for medical device manufacturers. We're looking forward to using and refining our quality management system in the months and years to come. - Susanne Ludvigsen, CEO, Aidee Health
A special thanks to MedQTech and Sofie Petersson for guiding us through the process using their excellent eQMS system MedQDoc.