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Medical Device Validation and Verification

Medical Device Validation and Verification

Toltec offers a wide range of independent validation and verification services to help you meet that challenge of complying with FDA's QSR and ISO's 13485 quality system directives. According to the FDA QSR, validation is the "confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled." Verification is "confirmation by examination and provision of objective evidence that specified requirements have been fulfilled." The following are validation and verification services we provide:

Validation and Verification

  • Planning
  • System level
  • Software
  • Mechanical
  • Electrical
  • Process validation
  • Field and/or clinical level
Validation and Verification


Testing strategy

Testing strategy

  • Writing specifications with verification in mind
  • Testing strategies
  • Particular strategies for software integration and test
  • Inspection strategies
  • Use of standards
  • Regression testing, how to manage test failures

Statistical tools

  • Determination of proper sample size
  • Single sided, double sided criteria
  • Normal distributions, other types of distributions, pass/fail tests
  • Adjusting stringency based on criticality of the selected parameter
  • Development of a statistical procedure for your quality system

Test protocol and V&V Plan development for validation and verification

Toltec's services include hands-on development of protocols and V&V plans for medical devices.  Toltec is highly experienced in developing V&V strategy and protocols for software, electronic hardware, mechanical components, and system level specifications.  Toltec's services will address the important technical needs in your V&V as well as the nuances required to deliver robust documentation that can survive a rigorous audit.

Test and V&V Plan execution and documentation of test reports

Execution of protocols and V&V plans require a high degree of discipline for proper execution and proper documentation practices.  Toltec's V&V personnel have a high degree of discipline, technical skill, and knowledge about how to execute and document the V&V documentation for medical devices.  

Copyright 2006 Toltec International, Inc. All rights reserved.

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