Capability statement
Software Quality Guru LLC
Medical device software quality, risk & cybersecurity, and design controls consulting
Overview
I help medical device teams build software that holds up to FDA and notified-body scrutiny. I've led software quality, design assurance and regulatory compliance at global medical technology and pharmaceutical companies, contract manufacturers and device startups, and I served on the teams that developed IEC 62304:2006/AMD1:2015 and ANSI/AAMI SW91:2018. I take on project and retainer work through Software Quality Guru LLC, remotely, with on-site visits when they help.
Company details
- Legal name
- Software Quality Guru LLC (Virginia limited liability company)
- Principal
- Frank Clay, CSQE
- Location
- Chester, Virginia · Remote-first, on-site when it helps
- Mailing address
- PO Box 2704, Chester, VA 23831
- Contact
- frank@softwarequality.guru · 804-587-7740
- Web
- softwarequality.guru
Core competencies
Software quality & V&V
- Classification and planning
- Verification and validation strategy
- Traceability
- SOUP, OTS and changes
Risk & cybersecurity
- Software risk analysis
- Threat modeling
- SBOM and vulnerabilities
- Premarket package and post-market plan
Design controls & regulatory
- Design controls
- QMSR and ISO 13485
- Usability engineering
- Submission documentation
Differentiators
- Development team member for IEC 62304:2006/AMD1:2015 and ANSI/AAMI SW91:2018
- SME reviewer for IEC 82304-1, AAMI TIR80002-3 and IEC 62304 second-edition drafts
- Hands-on: I write and review the evidence myself, not through a team of juniors
- Remote-first, with on-site time when it helps
Certifications
- ASQ Certified Software Quality Engineer (CSQE)
- Lead Auditor: ISO 13485, ISO 9001, AS9100D
- Lean Six Sigma Black Belt
- Certified ScrumMaster
Engagement types
Fixed-scope assessments · Project work (submissions, remediation, V&V) · Expert review of a submission or file · Monthly retainer · Internal audits · Training and workshops. Engagements run under a master services agreement and a statement of work for each project.