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Services

Freelancing as

  • Head of Quality Assurance

  • Head of Quality control unit

  • Regulator according to MDD 93/42 EEC

Consultation and operative activities

  • Consulation and operative activities:

  • Regulatory affair activities according to MDD 93/42 EEC and project support

  • Implementation of quality management systems

  • Implementation of risk management according to ISO 14791

  • Inspection preparation according to ISO 13485, 21 CFR 820 und 21CFR 210&211

  • Implementation of vigilance system according to MDD 93/42 EEC

  • Supplier inspections; self inspections
    (ISO 13485, GMP part I and II, ISO 9001, 21CFR820, 21CFR210 & 211)

  • Deviation management

  • Change control

  • Compilation of equipment qualification requirements

  • Compilation and evaluation of sterilization validations (steam sterilization, dry heat sterilization, asepetic processes according to ISO 13408)

  • Issuing of quality documents and translation of quality documents (German / English)

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