Mapping & Validation
As Medical Devices Inspectors become more familiar with the expectations of the Drug Inspectors for evidence of meeting labelled storage conditions, mapping and validation compliance is becoming an area of discussion during Medical Devices inspections.
The Medical Devices Regulations require that procedures are in place to address storage and handling requirements. If your product has specific storage requirements, then you need to be prepared to provide evidence that storage requirements are being met. We can develop programs and protocols for you which help provide evidence that your handling of products complies with storage requirements.