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SDLC Key Points & Cybersecurity for FDA
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Nanomaterials in Medical Devices
The Dynamic Duos
Sterilisation validations, EO vs Irradiation
Medical Device Package Testing
Reprocessing Challenges & Considerations
No repetition of animal testing
Bioburden determination on Medical Devices
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Questions from Notified Bodies
Clean and safe – the pure validation strategy
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Medical Device Pyrogenicity
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The post market surveillance
Ophthalmic delivery systems
Strategic Implementation of ISO 10993-17
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E&L study for drug-like medical devices
Handling Cytotoxicity Failure: not the end
Navigating through the jungle of ISO 11607
New Approach of Toxicological Risk assessment
Selecting correct deterministic CCIT method
ISO 10993-17:2023, what’s new
ISO TC 194 latest updates
Pre-clinical combined studies
New approach methodologies (NAMs)
MDR: challenges to compliance
EU importers, requirements from manufacturers
ISO 10993-18:2020, A Practical Approach
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S(p)oiler Alarm - Reusable Medical Devices
Breathing gas pathway devices
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Ethylene Oxide
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