Intertech Engineering Associates, Inc.

Development and Validation of a Thermodilatation System

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Development and Validation of a Thermodilatation System
Development and Validation of a Thermodilatation System

Intertech Engineering Associates, Inc. was awarded a project late in its design cycle to assist in the development and complete the validation of a thermodilatation system; an RF probe for the relief of benign prostate hyperplasia (BPH). The project goals were to improve the quality of the product and provide validation results to assist in the submission process. The product was an RF probe connected to an RF power generator through a PC platform with a Windows operating system. The client had selected Visual Basic as a programming language and was using Rational RequisitePro as the tool for traceability.

The initial responsibility was to provide a gap analysis, which was conducted for the software design to fill in any discovered design, validation and quality gaps, followed by working with the client to define the requirements for device submission. This included any engineering change suggestions for regulatory submission. Finally, documentation was produced for the validation of software tools. Several plans were delivered that included software development, verification and validation, configuration management and defect management plans. A final defect report was provided for issues that were resolved during the software design cycle. Quality system processes were developed and reviewed for design controls to ensure compatibility with the submission process. Testing was critical in the project scope and as such to demonstrate the thoroughness of testing, a testing matrix was developed from the requirements to the system and integration level tests that were developed.

Intertech was brought into the project at a late stage and effectively assisted in its completion in 7 months providing engineering and software validation services in addition to acting as a liaison for regulatory submission.


Thermodilatation System Project Highlights

Project Description
Device is an RF probe for relief of benign prostate hyperplasia (BPH). Client had major gaps in their quality system and Design History File for the device software, and practically nothing to show for software validation. The Client had been acquired. The acquisition was contingent upon submission and acceptance of the device’s pre-market notification. Our objective was to help plug the quality gaps and provide validation results to assist in the submission process.
Project Outcome
Device development and validation was completed. Regulatory submission was accepted by FDA on first submission and the product was successfully released to market. Due to the product’s successful release, the acquisition of our Client was completed successfully.
Type of Project
Validation, Quality System Development, and Regulatory Assistance
Tools Used
Processor Platform
  • PC
Operating System
  • Windows
Languages
  • Visual Basic
Technologies
  • RF Probe
Other Tools
  • Rational RequisitePro
Responsibilities
  • Gap analysis for software design and validation artifacts
  • Fill any identified design and validation gaps
  • Gap analysis for quality system design controls
  • Fill any identified quality system gaps
  • Work with client’s regulatory department to identify submission needs
  • Provide all outputs from engineering needed for regulatory submission
  • Provide validation and documentation for software tools
Deliverables
  • Software development plan
  • Software Verification and Validation plan
  • Configuration management plan
  • Defect management plan
  • Provided resolved defect report
  • Quality system processes and procedures for design controls
  • Test procedures for System and Integration level tests
  • Trace matrix from requirements to test procedures
  • Software architecture document
  • Design review minutes
  • Verification and Validation final report
Services Used
  • Quality system consultation
  • Software review and evaluation
  • Design History File gap analysis
  • Defect management
  • Configuration management
  • System level Verification test development and execution
  • Non-Device Software Validation
Processes Used
  • System engineering processes
  • Project management
  • Software Verification and Validation processes
Standards
Customer Specifications
Delivery/Turnaround Time
7 Months
Product Type
Thermodilatation System

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