Quality, safety, and reliability – certified for over 25 years

DiaSys GmbH has been certified according to international quality standards since 1996. Our ISO 13485, MDSAP, and IVDR certifications, as well as regular TÜV Rheinland audits, confirm that quality, safety, and reliability are our top priorities. We develop, produce, and distribute highquality in vitro diagnostics, reagents, and analyzers that meet the highest standards of patient safety and user-friendliness. This is based on our effective quality management system (QMS), which is implemented and continuously improved at all locations.

Our quality policy – in a nutshell

Our quality policy combines innovation with responsibility and is based on clear principles:

Customer satisfaction at the center

We exceed the expectations of our customers, partners, and users with safe and reliable products.

Quality comes from people

Our employees shape the quality that sets us apart with responsibility and team spirit.

Continuous improvement & innovation

We are constantly developing our products and processes to ensure that we meet the high standards of the diagnostics industry.

International standards

Our QMS is based on recognized standards and is regularly audited to ensure maximum transparency and quality.

Quality Policy

Certifications

Our quality has been tested and confirmed by independent bodies:

  • TÜV Rheinland, ISO 13485: Quality management for medical devices
  • MDSAP: Medical Device Single Audit Program
  • TÜV Reinland, IVDR: EU In Vitro Diagnostic Medical Devices Regulation

Product-specific IVDR certificates will be uploaded as soon as the products are rolled out on the market.

 ISO 13485 Certificate 
MDSAP Certificate

CE-Declarations

Our products comply with the applicable European requirements for in vitro diagnostic medical devices. The corresponding declarations of conformity are available for download here:

  • Reagents: Collective declaration for all reagents in combination with the analyzers from other manufacturers listed in the product catalog.
  • Analyzers: Separate CE declarations for the respons®, Stardust FC/MC, SensoStar, and InnovaStar® series with the applicable parameters.
  • Cooperation systems: Supplementary declarations of conformity for reagents marketed in cooperation with other manufacturers (e.g., JCA-BioMajesty® 6010/C). All documents are regularly reviewed, updated when changes occur, and made available on this page.

IVDR-Certification

The EU Regulation on In Vitro Diagnostic Medical Devices (IVDR) has been binding in all EU member states since May 26, 2022. It replaces the previous IVDD and introduces new requirements for risk classification, conformity assessment, and transparency for in vitro diagnostic medical devices in Europe. DiaSys began implementing the IVDR at an early stage and is working closely with the notified body TÜV Rheinland (0197) to this end.

The first product groups are already in the certification process, with others to follow gradually within the applicable transition periods. For our customers, this means that the availability of our products remains guaranteed. We are gradually transferring our portfolio to the IVDR, ensuring compliance with all relevant regulatory requirements.

Do you have questions about quality management at DiaSys?

QM@remove.this.diasys.de

Sustainability

Environmental awareness, energy efficiency, and social responsibility within our company as well as with a view to responsible collaboration.

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Governance

Transparent structures, clear compliance rules, and integrity-driven conduct.

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Overview

As a manufacturer of reagents and modern blood analysis devices, we assume responsibility.

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