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Upcoming Webinars/Seminars
Biological evaluation of Medical Devices
What is a "good" BEP?
Past Webinars/Seminars
Alternative Methods for Medical Devices
New ISO 18562 Series
Implementation of ISO 13485
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
Usability techniques for compliance
Special Hemocompatibility Testing
Questions from Notified Bodies
Clean and safe – the pure validation strategy
Pyrogens, alternative methods
Medical Device Pyrogenicity
CE/MDR versus FDA submission
The post market surveillance
Ophthalmic delivery systems
Strategic Implementation of ISO 10993-17
Stability studies of medical devices
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
Hemocompatibility Testing
Virus Clearance Studies (US FDA)
Virus Clearance Studies (EU)
S(p)oiler Alarm - Reusable Medical Devices
Breathing gas pathway devices
Reprocessing of Reusable Medical Devices
In-vitro testing/regulatory compliance
MDR submission
Ethylene Oxide
Navigating the Full Biocompatibility Workflow
Principles for Validation of Reprocessing
Biocompatibility Testing
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