+1.804.216.5559

Software Quality Guru
Software Quality Guru
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+1.804.216.5559

We offer expert software consulting in remote-first medical device quality, ensuring compliance with IEC 62304 and ISO 14971 standards. Based in the U.S., our flexible time zones allow us to provide top-notch quality assurance services tailored to your needs.

Software Quality Consulting

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We offer expert software consulting in remote-first medical device quality, ensuring compliance with IEC 62304 and ISO 14971 standards. Based in the U.S., our flexible time zones allow us to provide top-notch quality assurance services tailored to your needs.

Software Quality Consulting

Software Quality ConsultingSoftware Quality ConsultingSoftware Quality Consulting
Book a consultation

About Software Quality Guru

Expertise in Quality Assurance

Software Quality Guru provides expert software consulting to help medical device teams build and maintain audit-ready software quality, risk, and cybersecurity evidence without hindering development. We support SaMD, SiMD, and connected devices with IEC 62304 lifecycle governance, ISO 14971:2019 risk management, and submission-focused cybersecurity documentation, including SBOM governance, threat modeling, and traceable security controls.  


Our work is practical and evidence-driven: we repair traceability from requirements to verification, strengthen DHF and RMF defensibility, and improve CAPA and post-market documentation to ensure it withstands scrutiny. As a remote-first organization based in Chester, Virginia, we offer targeted remediation, fractional quality leadership, and rapid stabilization support for releases, audits, and regulatory interactions, ensuring robust medical device quality through our quality assurance services.

Our Solutions

IEC 62304 Rapid Readiness Sprint

Risk Traceability and RMF Stabilization

Risk Traceability and RMF Stabilization

Two doctors collaborating on a laptop, wearing white coats and stethoscopes.

Conducting a gap analysis against IEC 62304 expectations is crucial for medical device quality. Our expert software consulting services will help you develop a comprehensive lifecycle plan and remediation plan, along with necessary edits. We focus on traceability repair, ensuring that requirements, design, and verification evidence align seamlessly. Additionally, we provide SOUP inventory and governance recommendations that comply with ISO 14971 standards. The outcome is a defensible 62304 story that reviewers can easily follow, supported by our quality assurance services.

Risk Traceability and RMF Stabilization

Risk Traceability and RMF Stabilization

Risk Traceability and RMF Stabilization

A computer tower integrated with a blue and silver stethoscope.

ISO 14971:2019 Compliance is essential for medical device quality and involves thorough hazard analysis and risk control review. Our expert software consulting services ensure risk control verification is mapped to tests and objective evidence, while providing FMEA alignment guidance where applicable, particularly in accordance with IEC 62304 standards. We also offer recommendations for integrating post-market feedback, leading to a risk management framework (RMF) that is consistent, traceable, and backed by evidence, all of which enhances your quality assurance services.

FDA Cybersecurity Evidence Pack

Risk Traceability and RMF Stabilization

A gloved hand interacts with digital healthcare icons on a blue background.

An SBOM template combined with a governance approach, alongside expert software consulting, ensures robust threat modeling outputs such as TARA and STRIDE. This process includes a thorough security risk analysis that aligns with IEC 62304 and ISO 14971, featuring traceable controls and verification mapping for security controls. The outcome is a regulator-ready cybersecurity evidence set that supports medical device quality and quality assurance services, rather than just a slide deck.

CAPA Acceleration and Effectiveness Program Support

Professional team discussing CAPA process steps in a modern conference room meeting.

Investigation structure and cause mapping are integral to our expert software consulting practices, ensuring compliance with IEC 62304 and ISO 14971 standards. Our containment and correction plan includes effectiveness criteria that align with medical device quality and quality assurance services. We focus on trending and reporting improvements, complemented by audit response support and closure discipline. The outcome is a streamlined process resulting in faster closures, stronger evidence, and fewer repeat findings.

Validation and Compliance for Quality Systems Software (GAMP 5)

Validation and Compliance for Quality Systems Software (GAMP 5)

3D medical devices including smartphone app, blood pressure monitor, and thermometer.

A risk-based validation strategy, aligned with GAMP 5 standards, is crucial for expert software consulting in the medical device sector. This includes developing protocol and report templates that meet evidence expectations while integrating change control for sustainability. By adhering to IEC 62304 and ISO 14971 standards, we ensure that the outcome is a validation process that is both defensible and maintainable, reinforcing our commitment to medical device quality and quality assurance services.

Human Factors / Usability File Readiness (ISO62366-1)

Validation and Compliance for Quality Systems Software (GAMP 5)

Computer with a medical kit and stethoscope on the screen.

UE file structure review and gaps in alignment with IEC 62304 and ISO 14971 standards. Formative/summative readiness checklist to ensure compliance with medical device quality. Traceability alignment recommendations from our expert software consulting team. Outcome: A usability evidence set that aligns with expectations and supports quality assurance services.

Contact Us

Software Quality Guru

PO Box 2102, Chester, VA 23831

+1.804.216.5559

Hours

Open today

09:00 am – 05:00 pm

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