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STERILIZATION CONSULTING
SERVICES

MICROBIOLOGY AND STERILIZATION
CONSULTING FOR MANUFACTURES

Services provided to support ISO13485:2016/REGULATION (EU) 2017/745 requirements:

  • Introductory Training to sterilization and microbiology standards.
  • Environmental Control Program design
  • Quality and technical vendor audits
  • Internal audits
  • Sterilization Validation/Re-validation
  • Sterilization Release Procedures
  • Product Adoptions

CFR 211

CFR 820

ISO 13485:2016

ISO 9001:2015

TECHNICAL MICROBIOLOGY AND
STERILIZATION CONSULTING

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AAMI/ISO 11135

AAMI/ISO 11137

AAMI/ISO 11737

AAMI/ISO 17665

ISO 14644