Quality
Quality
Our quality management system is certified according to EN ISO 13485:2016 and registered according to FDA 21 CFR 820. Our quality management system covers all required standards and strives for continuous development and improvement of our system and processes.
Our quality management system is certified according to EN ISO 13485:2016 and FDA 21 CFR 820. Our quality management system covers all required standards and strives for continuous development and improvement of our system and processes.
Certifications
All manufacturing processes are validated according to EN ISO 13485:2016 and FDA 21 CFR 820 specifications. This also includes special processes carried out by long-term partners. Thus, we guarantee our customers the highest possible and reproducible quality of the products.
Validation
All manufacturing processes are validated according to EN ISO 13485:2016 and FDA 21 CFR 820 specifications. This also includes special processes carried out by long-term partners. Thus, we guarantee our customers the highest possible and reproducible quality of the products.
Technical documentation
Device History Record (DHR)
We ensure full traceability for all products we manufacture. The production records are archived so that we can ensure traceability back to the raw material used at any time.
Device Master Record (DMR)
We have technical documentation for every product and are happy to support you with the creation of your product as well as obtaining market permission.
Certifications
- EN ISO 13485:2016
- FDA registration #9610621 as Manufacturer and/or Contract Manufacturer
Validation
All manufacturing processes are validated according to EN ISO 13485:2016 and FDA 21 CFR 820 specifications. This also includes special processes carried out by long-term partners. Thus, we guarantee our customers the highest possible and reproducible quality of the products.
Technical documentation
Device History Record (DHR)
We ensure full traceability for all products we manufacture. The production records are archived so that we can ensure traceability back to the raw material used at any time.
Device Master Record (DMR)
We have technical documentation for every product and are happy to support you with the creation of your product as well as obtaining market permission.
