ווריפיקציה (אימות) וולידציה (תיקוף) של תכן במכשור רפואי - Design Verification and Validation for Medical Devices 21/10/2020
טכנולוגיה ניהול ביומד
The workshop will provide the knowledge and tools how to build a verification and Validation plans, protocols, execution and summary to comply with the FDA, ISO and CE Requirements. Link V&V with design process lifecycle and with Risk management, as well as with the Requirements for Usability and Software development lifecycle requirements.
Understanding of the framework for design verification and Design validation, risk analysis
Usability and Software lifecycle, to effectively meet the regulatory requirements of the FDA
MDD and ISO. Build an effective and cost and time saving V&V strategy. Practice through
Exercises and constructing elements of the V&V framework
- Terms and definitions in the world of V&V. - What are the Regulatory definitions FDA , ISO 13485:2016, MDD/MDR - Introduction to the related standards ISO 14971, IEC 62304, IEC 62366 - Design Planning, Design Input and Design Output. - Documents and records. - Design Verification Plan Structure and content - Verification plan exercise - Design Verification protocol/procedure elements and template - Design verification protocol exercise - Traceability to design inputs how to - Verification results records, do`s and don’ts - Verification Summary - Exercise on design records, and summary - Design Validation Plan Structure and content - Design Validation plan exercise - Design Validation protocol/procedure elements and template. - Design Validation and Usability how to save efforts - Design validation/usability protocol exercise - Traceability to design inputs which ones - Design Validation Vs Process Validation - Reliability assessment as part of Design Validation - Methods to reduce size of V&V (DOE, Monte Carlo etc.) high level introduction. - Usability and Human factor evaluation methods. - Risk analysis linked to validation - Exercise on design validation with Usability - Validation Summary report, elements, how used.