Webinars & Seminars

De l’ISO 9001 à l’ISO 13485

Réussir la Transition vers les Normes de Qualité des Dispositifs Médicaux

From ISO 9001 to ISO 13485:

Navigating the Shift to Medical Device Quality Standards

Workshop: Biocompatibility and Beyond

Workshop: Cardiovascular Device Testing

Medical Devices Used in Dentistry

Évaluation Biologique en Dentisterie

Navigate ISO 18562:2024

EO Sterilization at a Crossroads

Validation du retraitement : UE vs. FDA

Biocompatibility Testing:in vitro vs. in vivo

Biokompatibilitätstests: in-vitro vs. in-vivo

The Life Cycle Rises: Applying ISO 10993-1

Webinar: IEC 62304

Webinar: Regulatory & Market Access

Webinar: USP Class 6 Is Being Replaced

Webinar: From ISO 9001 to ISO 13485

Webinar: Cleaning Validation

Keep calm and be ready for new ISO 10993-1

Biocompatibility Deficiencies

Nanomatériaux dans les dispositifs médicaux

The Post Market Surveillance

When Devices Meet Medicines

Usability & ergonomic requirements for MD

Ready to tackle FDA registration

Reprocessing of Reusable Medical Devices

PFAS Medical Device Regulations

Biological Evaluation Plans

Sterilization Validations

SDLC Key Points & Cybersecurity for FDA

What is a "good" BEP?

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

Non conformities: how to answer them?

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

Prepare for USP 382

Ophthalmic Device Quality

Distribution Testing

More Than Meets the Eye

Max Ophthalmic Device

Biocompatibility Studies: Prepare for Change

Understanding ISO/DIS 10993-3 Updates

Live Q&A: PFAS