ISO 13485:2016 reconfirmed: Standard will remain unchanged until April 2030
13/01/2026
The reconfirmation of ISO 13485:2016 provides stability and supports better planning of quality strategies. Medical device manufacturers in Europe can use this advantage to focus resources on MDR implementation and ongoing compliance.
In accordance with the Federal Immission Control Act (BImSchG), operators of plants requiring authorization are obligated to have the type and scope of emissions from their facilities regularly assessed by an accredited measuring body, as notified under Section 29b BImSchG. Our experts conduct these emission measurements for a wide range of individual substances.
Functional testing and calibration of monitoring equipment
Regular functional testing and calibration are essential for the operation of automatic measuring systems (AMS) for emission monitoring. This ensures that the measuring equipment works precisely and that the measurement signals are correctly analysed and stored. This promotes both environmental protection and operational safety.