Medical Device Design Control - Quality System
Each manufacturer is required to establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured and that meets the requirements of Part 820. Therefore, the details of design control systems will vary depending on the complexity of the product or process being designed.
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ISO 13485 Internal Auditor Checklist
Price: $95.00
Price: $95.00
Quality System Regulation (QSR) Management Responsibilities
Quality System Regulation (QSR) - 21 CFR Part 820 - FDA Paperwork Act submission for QSR - FDA’s Quality System Inspection Technique (QSIT) Quality system procedures
Quality System Regulation (QSR) - 21 CFR Part 820 - FDA Paperwork Act submission for QSR - FDA’s Quality System Inspection Technique (QSIT) Quality system procedures
What are DHF, DMR and DHR? - The FDA Quality Systems Regulations Records Explained
FDA Quality Systems Regulations -Product Development Life Cycle -Design History File (DHF) -Device Master Record (DMR)- Device History Record (DHR)
FDA Quality Systems Regulations -Product Development Life Cycle -Design History File (DHF) -Device Master Record (DMR)- Device History Record (DHR)
QSR Device Inspections - Transition from “Barely Surviving” to “Gaining Control”
Definition of Quality System Regulations (QSR)- Management Control-CAPA-Design Controls - Production and Process Controls (P&apm;PC)
Definition of Quality System Regulations (QSR)- Management Control-CAPA-Design Controls - Production and Process Controls (P&apm;PC)
ISO 13485 - Medical Devices: Quality Management Systems
Overview - key requirements - written procedures and training are required - internal audits
Overview - key requirements - written procedures and training are required - internal audits
