Vetrto Tech

Medical Device QMS

Course Overview

This training focuses on understanding design controls for medical devices in accordance with current FDA regulations and learning how an effective Process Validation system is a critical requirement towards a risk-based approach to compliance and product safety.

Topics to be discussed include

  • 21 CFR Part 820 – QSR scope, definitions and requirements
  • Class I, II, III Medical Device Classification
  • Overview of ISO 14971:2007 and EN ISO 14971:2012 Risk Management standards
  • Discussion of Various Document types – Product Specification, Marketing Specifications, Design Reviews, Design Verification Plan, Design Verification Report, Design Validation Plan, Design Validation Report, Test Method Validation, Design Transfer Plan, Risk Analysis, Design History File
  • Discussions on V&V Strategies, statistical methods, Reliability Assessment, Test Method Validation

  • FTA
  • PHA
  • Process Validation Compliance Requirements
  • Process Validation Elements – Validation Master Plan, Equipment Installation, Operation and Performance Qualifications (IQ, OQ, PQ), Validation Reports
  • Use of Statistical Tools in Validation – Process Capability, T-tests, ANOVA, Data Types