Med-Tech MasterClass Part Three: Medical Device Packaging Validation Regulatory Essentials
This time we will be discussing Medical Device Packaging Validation: Regulatory Essentials. We will look at :
💉 Sterile Packaging Requirements (including testing)
âš• Non Sterile Requirements
🔬 Statistical Sampling Requirements during validation
😷 Cleanroom Requirements
We will discuss:
- ISO 11607: Packaging for terminally sterilized medical devices,
- EN 868, ASTM Standards,
- ISO 11135: Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices.
How this fits into your Device Development for submission to Regulatory Authorities for FDA, MDR and ROW submissions.