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Regulatory Requirements

Getting Started

Introduction

Quality Management System

Establish Quality Management System
Training
Purchasing, Sales and Suppliers
Computer System Validation
Audits and Review

Planning

Device Characteristics and Classification
Design and Development Plans

Design and Development

User Needs
Risk Management
Product Requirements
Design
Design Stage Checklists

Verification and Validation

Usability and Human Factors Engineering
Manufacturing
Verification and Validation Planning
Verification and Validation Reports
Verification and Validation Stage Checklists

Regulatory Preparation

Labeling, Instructions for Use, and Manuals
Post-Market Surveillance
Clinical Evaluation
Performance Evaluation
General Safety and Performance Requirements Checklist
Deployment

Submission

Product Release
Declaration of Conformity
UDI Creation and EUDAMED Registration
Technical File
Medical Device File
FDA Registration
FDA Submission
- Overview
- FDA 510(k) ESTAR

Post Market

Product Changes
CAPAs and Vigilance
Surveillance Reports
Complaints

FDA Submission

FDA 510(k) ESTAR

Prepare electronic submission demonstrating substantial equivalence for FDA clearance and market authorization.

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