QUALITY MANAGEMENT
Hipp & Son manufactures quality made in Germany since 1920. This explicitly comprises systematic and replicable modes of operation. We effectuate our ISO 13485:2016 and FDA 21 CFR 820 conforming quality management system and continuously work to improve it. This task is jointly accomplished by all members of Hipp & Son.
Together with our business partners, we are forerunners in products and processes conforming with EU-MDR. According to our principle ‘From Sketch-to-Approval’, we support you in full extent.
FDA Listing 8010252
Product safety
- Homogenous quality through extensive product specifications and corresponding product examinations
- Complaints are registered and analyzed
- Regular maintenance of the risk management file
Validations
- All manufacturing processes are validated according to IMDRF Guidelines and fulfill ISO 13485 and 21 CFR specifications. This also comprises the special processes implemented by external partners.
- If needed, we issue workflows with main manufacturing procedures and provide validation reports to OEM partners for these processes.
Technical Documentation
- Device History Record (DHR) / Production records
- We secure exhaustive traceability for all manufactured products
- Device Master Record (DMR) / technischal documentation – we support you in EU MDR and FDA conformeing technical documentation
