To complement our quality management system, we have implemented a compliance management system to ensure that, in addition to systematically improving our processes, all legal and internal requirements relating to conduct and ethics are observed, thus preventing harmful consequences for our company.

Quality management and regulatory affairs

Since 1996, DiaSys Diagnostic Systems GmbH has been certified according international quality management standard. The certification and annual monitoring audits are performed by the TÜV-Rheinland.

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Compliance management

As part of the implementation of our compliance strategy, we have set up a comprehensive Compliance Management System (CMS) in accordance with ISO 37301 to ensure ethical and legally compliant behavior by our company.

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Since 1996, DiaSys GmbH has been certified according international quality management standards.

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Declarations of conformity

DiaSys GmbH was one of the first manufacturers declaring in 2000 conformity with directive 98/79/EC for In-Vitro-Diagnostics.

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The In Vitro Diagnostics Regulation (IVDR) has become effective on May 26, 2017. It replaces the existing In Vitro Diagnostics Directive (IVDD).

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