In April 2018 puracon successfully converted its certification from EN ISO 13485:2012 and AC:2012 to EN ISO 13485:2016.

Unlike its previous version, the EN ISO 13485:2016 highlights the risk-based approach of processes even more, which is implemented accordingly and being used by all employees at puracon.

Therefore the EN ISO 13485 forms the foundation of the quality requirement at puracon regarding processes, suppliers, employees and consequently also the quality of the delivered products – our motto isn’t for nothing: Quality accomplishes satisfaction for customers and safety for patients, user and third parties!

 

The new certificat can be downloaded HERE.