Expertise
Three areas, one goal: software evidence that holds up
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.
Software quality & V&V
I help device teams run an IEC 62304 lifecycle that produces the right evidence the first time: a safety class you can defend, a plan sized to it, and verification and traceability a reviewer can follow from requirement to result.
- Classification and planning
- Verification and validation strategy
- Traceability
- SOUP, OTS and changes
Risk & cybersecurity
I connect software to the risk file and security to safety. That means software risk analysis built on your real architecture, and a cybersecurity package that gives FDA the evidence it now expects for connected devices.
- Software risk analysis
- Threat modeling
- SBOM and vulnerabilities
- Premarket package and post-market plan
Design controls & regulatory
I help teams keep design controls, usability and the quality system in a state that holds up to an FDA inspection or a notified-body audit, and assemble software documentation that reads as one coherent story in a submission.
- Design controls
- QMSR and ISO 13485
- Usability engineering
- Submission documentation
Standards I work with every day
IEC 62304 · ISO 14971 · IEC 62366-1 · IEC 82304-1 · AAMI TIR57 and cybersecurity · QMSR (21 CFR 820) · FDA software guidance