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18Min 46Min
18Min 46Min

Competent Authority Update on Preparing for IVDR Clinical Performance Study Applications

Nebojsa Serafimovic
Nebojsa Serafimovic
BASG - Austrian Federal Office for Safety in Health Care,…
Free
1 Lesson | Duration 29Min

Critical Considerations in Site Selection and Subject Enrollment in Device and IVD Clinical Studies

Matteo Mosso
Matteo Mosso
Donawa Lifescience, Italy
Free
1 Lesson | Duration 34Min

Competent Authority Expectations and Management of Device Clinical Study Applications Under the MDR

Tom Melvin
Tom Melvin
Health Products Regulatory Authority (HPRA), Ireland
Free
1 Lesson | Duration 22Min

Developing Clinical Investigation and Performance Study Plans That Meet Regulatory and Operational Requirements

Daniela Karrer
Daniela Karrer
Donawa Lifescience, Italy
Free
1 Lesson | Duration 46Min

General Data Protection Regulations in the EU

Danielle Giroud
Danielle Giroud
MD-Clinicals SA, Switzerland
Free
1 Lesson | Duration 27Min

Aligning Clinical Investigations and Risk Management to Ensure MDR Compliance

Maria Donawa
Maria Donawa
Member of the Board, EAAR, President, Donawa Lifescience, Italy
Free
1 Lesson | Duration 29Min

MDR Requirements for Sponsor GCP Inspections (audits) and How to Conduct Them

Maria Donawa
Maria Donawa
Member of the Board, EAAR, President, Donawa Lifescience, Italy
Free
1 Lesson | Duration 45Min

Standards, Harmonisation Process and Common Specifications

Nils-Åke Lindberg
Nils-Åke Lindberg
Member of the Board, EAAR; CEO, QAdvis, Sweden
Free
1 Lesson | Duration 29Min

General Safety and Performance Requirements under the Medical Devices

Claire Murphy
Claire Murphy
EAAR Member of the Board, Consulting Partner, Tecno-med Ingenieros, SL,…
Free
1 Lesson | Duration 29Min

Software, Artificial Intelligence and Cybersecurity in the European Union

Robert Ginsberg
Robert Ginsberg
EAAR Member of the Board, Chairman of the Board, QAdvis,…
Free
1 Lesson | Duration 27Min