Document management for global standards and regulations
Audit, accounting and advisory
Document management for global standards and regulations Get white paper
Audit, accounting and advisory View industry
Interacoustics: Tuning up quality for global compliance
Interacoustics, a leading Danish medical device manufacturer and part of The William Demant Group, needed a unified system to manage regulatory compliance across its global operations. By implementing Ideagen, they streamlined their quality management processes and achieved compliance with stringent global standards, including FDA 21 CFR Part 820 and ISO 13485.

Key achievements

Compliance with FDA 21 CFR Part 820, ISO 13485, and European Medical Device Directives
Scalability across Denmark, Germany and US offices

Flexibility to meet specific needs across different departments.
Ideagen Quality Management
Trusted by more than 6,000 customers worldwide to digitalize their quality management processes and comply with industry standards.
Learn moreIntroduction
Interacoustics designs and manufactures audiological equipment used worldwide. To meet the strict requirements of international regulations, they needed a comprehensive quality management system (QMS) that could unify and streamline their compliance activities.
The challenge
Interacoustics faced several challenges with their previous manual processes:
- Managing complex regulatory compliance across multiple global locations.
- Ensuring consistency and accuracy in document control and auditing.
- Identifying opportunities for continual improvement in their quality management processes.
Finding the right solution
Interacoustics selected Ideagen Quality Management due to its ability to centralize and automate quality management activities.
The solution offered:
- Seamless scalability to meet the needs of all global offices.
- Comprehensive compliance management tailored to international standards.
- Integration across various departments, from production to management.
Implementation and impact
The implementation significantly transformed Interacoustics' quality management:
- Automated workflows replaced manual processes, reducing time spent on document control and auditing.
- Centralized data management ensured up-to-date and accurate information, improving visibility and control.
- Expanded system adoption beyond the quality department, integrating Ideagen into production, design, marketing, and management.
- Proactive improvement tracking allowed for identifying and addressing potential issues early, enhancing overall quality and compliance.
[Ideagen Quality Management] has become an integral part of our processes. It tells the story of what has happened in a certain case, whether it’s the control of a document or the management of an incident. This has enabled us to be more efficient and compliant across our global operations.
Hanne Nielsen, Quality Manager, Interacoustics
Real results
Ideagen has proven to be a reliable and efficient solution for Interacoustics, helping them manage their compliance activities across multiple global locations. The system’s scalability and flexibility have become vital tools in the company’s quality management strategy.
With the adoption of Ideagen Quality Management, Interacoustics saw:
Streamlined compliance across global operations.
Improved operational efficiency through automation.
Enhanced collaboration with Q-Pulse adopted across multiple departments..
Ideagen Quality Management
Trusted by more than 6,000 customers worldwide to digitalize their quality management processes and comply with industry standards.
Learn moreAbout Interacoustics
Interacoustics, part of the William Demant Group, designs and manufactures a wide range of audiological equipment, from small portable devices to full clinical instruments. Their products are used globally wherever hearing healthcare is practiced.
- 800+ employees worldwide
- Founded 1967

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