Case Study: Interacoustics achieves a fast, reliable quality system and regulatory compliance with Ideagen Q‑Pulse

Interacoustics implement Q-Pulse for fast and reliable quality system

Interacoustics, a Danish medical device manufacturer and part of the William Demant Group with offices in Denmark, Germany and the US, needed to replace a manual QMS to meet strict regulations (ISO 13485, FDA 21 CFR 820, CMDR and EU directives). The company required a single, scalable system for document control, audits and corrective & preventive actions (CA/PA) that would support role-based access, enable cross-office collaboration and help measure QMS effectiveness and continual improvement.

Ideagen implemented Q-Pulse as a fully integrated compliance management solution—deploying Document, CA/PA, Assets, Audit and Analysis modules with dynamic permissions—and rolled it out across production, design, marketing, product management and quality. The system scaled to all three offices, delivered regulatory compliance, streamlined processes, improved tracking and incident visibility, and made compliance faster, more reliable and more efficient while enabling ongoing improvement.

Interacoustics

Hanne Nielsen

Quality Manager