regulatory compliance and

Technical docu­mentation

Best practices and assured quality – compliant with MDR

At ASKION, all our development and production activities adhere to the highest standards of quality assurance. To meet the increasing regulatory requirements in medical engineering and diagnostics, we have extended our product portfolio with respect to technical approval and creation of the required documentation. Rest assured that your product will be compliant with the new Medical Device Regulation (MDR 2017/745).

Technical documentation
and regulatory compliance

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Certificate DIN EN ISO 9001

Certificate DIN EN ISO 13485

Our

References

Your

CONTACTS

Askion OEM Service Egon Pfeifer

Dr. Egon Pfeifer

Marketing & Sales

Lutz Warzemann

Project manager

Logo TMWWDG
Logo Europaeische Union

Under the consulting guidelines of the Free State of Thuringia, our company receives funding for consultations and process support. These support strategies for the establishment and sustainable positive development and securing of SMEs. The resulting findings and recommendations are documented in a consulting report. The funding is provided from the European Social Fund Plus and the funds of the Free State of Thuringia.

Our company receives funding from the European Union via the FTI-Thüringen Technologie guideline. In this project, a test platform is being developed on which various assemblies, materials and functionalities for biobanks can be tested independently of the device. The purpose of the project is to react flexibly and quickly to changing device requirements using the platform’s testing capabilities.

Through the FTI-Thüringen Personen guideline, our company receives funding from the State of Thuringia from the European Social Fund Plus for innovative employees in the field of fluorescence microscopy (2024 INP 0122). The topics are development, testing and optimization of fluorescence microscopes in different sizes and functions as well as the identification of functional requirements for the devices.

Through the FTI-Thüringen Personen guideline, our company receives funding from the State of Thuringia from the European Social Fund Plus for innovative employees in the field of biobanking (2024 INP 0132). Innovative software solutions for cryo devices are developed. A special focus is on IT security, modularity and flexibility of future device generations.

Sponsored by the Federal Ministry of Education and Research

KMU-innovativ

FKZ: 13GW0636D

RUBIN – NeuroMiR

FKZ: 03RU1U052B