Moscow, Russia

Meeting no
15
Date
-
Location
Moscow, Russia

General updates

Presentation: Improving the quality of international medical device standards for regulatory use
Presentation: How the Guidance Supports the Goals of Regulatory Harmonization
Presentation: Guidance Structure and Key Proposal
Presentation: How standards are used for regulatory purposes among IMDRF members
Presentation: Optimized standards to support essential principles of safety and performance of medical devices
Presentation: How IEC can contribute to IMDRF to support regulatory convergence
Presentation: Test methods in standards requirements and proposals
Presentation: How new work items come to be Good standards development practice
Presentation: SWG Optimizing Standards for Regulatory Use
Presentation: Use of improved Standards from the Russian industry perspective
Presentation: Why standards that follow the guidance are good for business
Presentation: Future of ISO 13485 and update on ISO 14971
Presentation: The future of the IEC 60601 SERIES
Presentation: Optimizing Standards for Regulatory Use_keynote summary
Presentation: FDA Overview on NGS Testing
Presentation: Next Generation Sequencing
Presentation: NGS Dx & EU Regulation
Presentation: NGS First Genetics
IMDRF Presentation - Stakeholder - AHWP Update
IMDRF Presentation - Stakeholder - APEC Update
IMDRF Presentation - Stakeholder - DITTA Update
IMDRF Presentation - Stakeholder - EAEC Update
IMDRF Presentation - Stakeholder - GMTA Update
IMDRF Presentation - Stakeholder - IAMT Update
IMDRF Presentation - Stakeholder - IMEDA Update
IMDRF Presentation - Stakeholder - PAHO Update
IMDRF Presentation - Stakeholder - WHO Update

Working group updates

Adverse Event Terminology
Good Regulatory Review Practices
Medical Device Clinical Evaluation
Medical Device Cybersecurity
Personolized Medical Devices
Regulated Products Submission
Unique Device Identification