Providing a full range of consulting, training, and auditing services that help clients 
            improve software quality, reduce time to market, and ensure compliance with applicable standards and regulations.

Medical Device Industry

Consulting, training and auditing services to help your organization comply with relevant FDA regulations, guidance documents and international standards:

    • Compliance with FDA regs, Design Controls, and Guidance documents
    • Software development, Verification & Validation
    • Compliance with IEC 62304 Software Development Lifecycle
    • Risk Management and compliance with ISO 14971
    • MDDS development using AAMI SW87 guidance
    • Training in Software Development for Medical Device Manufacturers

    Nuclear Power Industry

    Commercial Grade Dedication services to help qualify software for use in
    safety-critical areas:

      • Compliance with ASME NQA-1, NRC Regs, and EPRI Guides
      • Evaluation of existing software inventory
      • Assessment of current software procedures
      • Development and execution of Commercial Grade Dedication Plans

      Transportation Industry

      Consulting, training, and auditing services for software used in
      safety-critical areas:

      • Assessing compliance of software subcontractors to standards and regulations
      • Performing risk assessments and identifying safety cases
      • Functional, in-process and compliance audits