Regulatory Support

As important as your product, is the corresponding paperwork that has to accompany the project at all stages through to the point of market authorisation.

Our ISO certifications as well as our professionalism and regulatory skills ensure that you and your product are in safe hands at Aero Pump.

  • DIN EN ISO
    Aero Pump is certified under DIN EN ISO 9001, 14001, 15378 and 50001.
    The following documents can be provided upon request:
    - Raw material documentation
    - Drawings
    - Material data sheets
    - SOPs (if needed for registration)
     
  • DMF
    We have a DMF lodged with the US FDA. LoA‘s can be provided upon request.

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