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
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