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).

  • Certified according to ISO 9001 and ISO 13485
  • Production is audited by FDA
  • Risk analyses according to DIN EN ISO 14971:2012
  • Safety of laser according to DIN EN 60825
  • Electrical safety according to DIN EN 60601
  • EMC and ESD pretests within own laboratory
  • Technical documentation using medical device file (MDF) and device master record (DMR)

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

Our company receives funding from the European Union through the InnoInvest guideline. This project supports the purchase of a CNC milling machine and the investments required for its installation. The CNC milling machine is used for the production of plastic parts. It is a process innovation that optimizes established products or manufactures them more cost-effectively or in a more resource-efficient manner.

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