Kees Fremery

Advise & Training

More than 20 years experience

Sterile Medical Devices with knowledge of all validation techniques

Validation Advise

Consultancy and Training in the field of:

- Support in ISO 11137 - ISO 11135
- Microbiological Sterilization Validation
- Process Validation (Dose Mapping)
- Quality Management Systems / Technical Files
- Maintaining Process Effectiveness
- Training of cleanroom Technicians

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Troubleshooting

Support when failing a periodic Dose Audit or Bioburden is drifting and not in control

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Monitoring

Microbiological monitoring of cleanrooms and classified production locations is an issue which gets more and more attention

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Kees Fremery

Kees Fremery Advies & Training offers a complete range of advise and training to companies in the Medical Device Industry.

This includes the complete validation process to ensure and maintain the sterility claim on your product.

More than 20 years experience in Radiation Sterilization and Microbiological Testing of Medical Devices.