Case Study: Hettich achieves MDR and IDR compliance with Perforce Helix ALM

How Andreas Hettich GmbH & Co. KG Achieved MDR and IDR Compliance Through the Traceability of Helix ALM

Hettich, the Germany-based manufacturer of centrifuges and incubators, needed a planning and tracking tool with precise, automated traceability to meet strict medical device and in vitro device regulations. The team had to ensure compliance, maintain product quality, and pass audits quickly while managing a complex development workflow. Perforce Helix ALM was used to support these requirements.

Perforce implemented Helix ALM with a highly configurable workflow engine and end-to-end traceability reports, allowing Hettich to document requirements, risk management, bug tracking, and testing automatically. This helped Hettich achieve MDR and IDR compliance, streamline a recent audit, and save significant time and resources by making regulatory adherence easier to demonstrate.

Hettich

Konstantin Koshel

Hettich