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Training: Basic Biocompatibility – Practical Perspective & Regulatory Aspects
Speakers: Monica Grekula & Lina Burman Date: November 21 and 26, 2024 Duration: 6 hours | 2x 8:00 – 11:00 AM (US Eastern Standard Time), 2x 2:00 –...
Trainings
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Artificial Intelligence (AI) in the Medical Device Industry
Speaker: Somashekara Koushik Ayalasomayajula, Quality and Regulatory Affairs Director
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ISO 14155:2020 Clinical Investigation of Medical Devices — Good Clinical Practice
Speaker: Dr. Jérôme Randall, Senior Associate
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In Vitro Diagnostic (IVD) for Pharma and Biotech: LDT/CDx
Speaker: Dr. Silvia Anghel, Head of IVD Group Date: September 26th 2023, Online Duration: 2 hours | 3:00 – 5:00 PM CEST, 9:00 – 11:00 AM EDT Training...
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IEC 62366-1:2015 – Usability of Medical Devices
Speakers: Linda Ahnen, Director, Quality & Regulatory Affairs and Serge Dubeau, VP, Human Factors Engineering
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In Vitro Diagnostics for Pharma and Biotech – In-House Devices (LTD) / CDx in Europe
Speaker: Dr Silvia Anghel, Sr Director, Quality and Regulatory Affairs
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US Regulations for EU Companies – Introduction to the FDA Regulations for Medical Devices
Speaker: Paige Elizabeth Sutton-Smith, Project Associate
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Understanding the EU Regulatory Landscape for Software as Medical Device (SaMD)
Speaker: Somashekara Koushik Ayalasomayajula, Quality and Regulatory Affairs Director
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Basic Biocompatibility – Practical Perspective & Regulatory Aspects
Speakers: Monica Grekula & Lina Burman, Biocompatibility Experts
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Clinical Investigation of Medical Devices — Requirements of ISO 14155:2020 – Good Clinical Practice
This Good Clinical Practice (GCP) course, certified by Swissethics for both Investigator and Sponsor-Investigator level for clinical investigation...