Software QA

Software verification, validation and testing procedures and protocol, and preparation of software submission files.

Key Software QA Services:

  • Write software design procedures per FDA and CE requirements.
  • Meet the FDA software guidance, CE requirements, safety requirements for Programmable Electronic Medical Systems and software contained in medical devices.
  • Help develop policies and procedures tailored to your company and specific classes of application.
  • Provide hands-on assistance to coach your staff during specific verification, validation and testing.
  • Software verification and validation (V&V): define risk-based plans for validation and procedures for validation that allow variability based risks.
  • Define policies to interpret FDA (AMMI/SW68 and TIR) or CE (IEC 62304) for your organization.
  • 510(K), IDE, and PMA software submissions for all classes of devices.
  • Software hazard analysis and risk management, including conformance to standards.
  • Design Control Procedures (Software life cycle phases).
  • Software technical reviews, process measurement, and process improvement.
  • Implementation of effective, compliant quality systems, design control, and software development standards, for large and small companies and groups.

Turning your product into reality