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Hipp and Son
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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.

ISO 13485:2016 certificate

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

G. Hipp & Sohn GmbH

Carl-Benz-Straße 1
D-78579 Neuhausen ob Eck
Telephone +49 7467 1463
Email info@hippandson.com

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