certifications

We consider it as our business objective to develop, produce and market high quality products which meet the long-term requirements of our customers and offer the maximum safety for patients and (medical professionals) users.

Since this objective can only be accomplished with the continuous development of the products and the processes involved Stihler Electronic decided to establish the entire organisation and all operational processes on the basis of

EN ISO 13485 as well as on the 
EC Directive 93/42/EWG for medical products and (EU) 2017/745 on medical devices (MDR) (class I products)

and secure them long-term.

» You can find our current EN ISO 13485 certificate here:

Certificate for Quality Management EN ISO 13485:2016 + AC:2018 + A11:2021

Notified Body Confirmation Letter on the extension of MDD Certificates 50192-16-06 and 50192-17-08

Certificate for Quality Management EN ISO 13485:2016 MDSAP

EC Certificate for the Quality Assurance System Annex V_ASTOTUBE

EC Certificate for the Quality Assurance System Annex II_ASTOPAD, ASTOFLO PLUS ECO, ASTOTHERM PLUS, PRISMAFLO II S, PRISMATHERM II