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Support FDA Reapproval Sunbed

Unterstützung FDA-Neuzulassung Sonnenbank

Task

  • Preparation/supervision of an FDA 510(k) pre-submission
  • Revision of the technical documentation and preparation of the FDA 510(k) submission
  • Revision of the QM system with regard to the requirements of 21 CFR 820 – Quality System Regulations
  • Participation in FDA pre-submission meetings

Do you have any questions?

Our colleagues are happy to answer any questions you may have.

Linus Yman

Linus Yman

Sales Manager

Benjamin Klein

Benjamin Klein

Sales Director

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