Validation Advise

ISO 11135 - ISO 11137

Every claim on a Medical Device label requires evidence...

Sterility: Microbiological Validation
Expiry Date: Packaging Validation
Sterilization parameters: Process Validation
Maintaining process effectiveness:  Periodic Dose Audits


  • Advise to producers of Sterile Medical Devices based on the Standards ISO 11137 and ISO 11135 and supporting standards
  • Support in:
    • Product Validation (Microbiological Validation)
    • Process Validation (Dose Mapping)
    • Writing Validation Master Files, Validation Studies and Technical Files
    • Training of Production and Management in the relevant standards
    • Training of Cleanroom Technicians (Cleanroom awareness and behavior)
    • Microbiological monitoring of classified Cleanrooms and a-septic Production locations
    • Accompaniment of customers during product- and process validation
    • Support during Audits
Validation Advise

My mission is not to solve your problem but teaching you to solve it. 

Wise words: 

Hiring experts will cost money but in the end will save you much more.


Validation Advise

Creation of complete Validation Master Files:

  • Site Master File
  • Validation Master File
  • Creation of Product Families
  • Creation of Processing Categories
  • Validation Protocol
  • Standard Operation Procedures
  • Maintaining Process Effectiveness
Validation Advise

Training and Advise is given in easy understandable wordings. 

This makes it possible that you can solve it yourself next time it happens again.

You can only be trained by someone who knows and understands the topic.