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.

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Key achievements

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Compliance with FDA 21 CFR Part 820, ISO 13485, and European Medical Device Directives

Scalability across Denmark, Germany and US offices

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Flexibility to meet specific needs across different departments.

Company overview

About 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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