Product/Service

Verification & Validation

Source: East Development Group
Complying with U.S. FDA cGMP requirements and European medical device directives means that your company has to provide
Complying with U.S. FDA cGMP requirements and European medical device directives means that your company has to provide a high degree assurance that your products, and the processes used to manufacture your products, consistently meet specified requirements. EDG offers a wide range of independent validation and verification services to help you meet that challenge. Whether it's device design validation, software validation or manufacturing process validation, we know what it takes to ensure that your product meets domestic and international quality standards.

Product and Process Validation Planning Including the Following:

  • Product and Process Requirements Analysis, Specification and Verification

  • Software Verification and Validation Planning

  • Fault Tree Modeling

  • Design Specification and Verification

  • Failure Modes and Effects Analysis

  • Validation Test Design and Implementation

  • Code Inspections and Walk Through

  • "White Box" and "Black Box" Test Design and Documentation

  • Vendor Qualification

  • Defect Tracking

  • Configuration Management

  • Design History Documentation Including Specifications, Plans, Design Review Minutes, Test Protocols and Results

    East Development Group, 141 Washington Street, East Walpole, MA 02032. Tel: 508-660-9045; Fax: 508-660-6946.