Software Quality Guru LLC · Remote-first consulting
The software quality partner your next submission needs.
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.
Bring me in on your submission, audit or remediation
Software quality, design assurance, risk and cybersecurity work for medical device teams, by the project or on retainer. Remote, with on-site visits when they help.
Use my free tools and templates
The 62304 safety class calculator, plus SOUP, SBOM, software FMEA and change impact templates.
Get the free templates →Software quality and design assurance at global medical technology and pharmaceutical companies, nutraceutical manufacturers working to pharmaceutical cGMPs, contract manufacturers, neuromodulation and device startups, and now independently through Software Quality Guru LLC
Standards work & credentials
- IEC 62304:2006/AMD1:2015Medical device software: Software life cycle processesDevelopment team
- ANSI/AAMI SW91:2018Classification of defects in health softwareDevelopment team
- IEC 82304-1:2016Health software, Part 1: General requirements for product safetySME reviewer
- AAMI TIR80002-3:2016Medical device software, Part 3: Process reference model of medical device software life cycle processes (IEC 62304)SME reviewer
Certified: ASQ Certified Software Quality Engineer (CSQE) · Lead Auditor: ISO 13485, ISO 9001, AS9100D · Lean Six Sigma Black Belt · Certified ScrumMaster
Service: Past Vice Chair, Technology, ASQ Software Division · Past Chair, IEEE Computer Society Chicago Chapter · ANSI Associate · IEC subject-matter expert
Expertise
What I can take on for you
Software quality & V&V
IEC 62304 lifecycle from planning to maintenance, with verification and validation that an auditor can follow.
- 62304 safety classification and process gap analysis
- Software V&V strategy, protocols and traceability
- SOUP/OTS evaluation and change impact analysis
Risk & cybersecurity
Software risk that ties hazards to software items, and premarket cybersecurity that matches what FDA now asks for.
- ISO 14971 software risk and software FMEA
- Threat modeling and TARA (AAMI TIR57)
- SBOM, 524B and cyber device submissions
Design controls & regulatory
Design controls under QMSR, usability under IEC 62366, and submission documentation that holds together.
- Design history and design review readiness
- QMSR / ISO 13485 gap assessment and internal audit
- 510(k) software documentation (Basic vs Enhanced)
Free tool
What IEC 62304 safety class is your software?
Five questions that follow the clause 4.3 decision tree. You get the likely class (A, B or C) and the lifecycle deliverables that class requires, with clause references. Email yourself the PDF if you want to keep it.
Try the free 62304 calculatorDecision support only. It doesn't replace your documented classification rationale.
- 1Can a failure of the software contribute to a hazardous situation?
- 2Are there risk controls external to the software?
- 3What is the worst credible harm?
- →Likely class + deliverables checklist
From the blog
Recent notes
November 9, 2026
Inspections After QSIT: An Auditor's Read of FDA's New Playbook
QSIT is retired, and FDA investigators now scope device inspections from your own risk documentation and follow the evidence across QMS areas. Here is how Compliance Program 7382.850 runs, read from the lead auditor's chair, and how I can help teams host it.
November 7, 2026
QMSR Inspections: Your Management Review Is Now Evidence
Since the QMSR took effect, FDA investigators can read management review, internal audit and supplier audit records directly. Here is how the new inspection program uses them and how I prepare a QMS without rewriting history.
November 2, 2026
Software Verification vs. Validation: Evidence That Holds Up
Passing tests prove the software meets its specification, not that the device meets user needs. Here is where ISO 13485, IEC 62304 and FDA guidance draw the line between verification and validation, and what I check before a V&V package goes out.