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.
When teams bring me in
- You're preparing a 510(k), De Novo or PMA and need the software documentation reviewed or assembled
- Your procedures still reflect the old QSR and need to match the QMSR and ISO 13485
- A design review, audit or inspection is coming and you want an independent read first
- Usability work and the risk file don't line up
What you get
- Design control procedures and DHF/medical device file review
- QMSR gap assessment and remediation plan
- Internal audit reports
- Usability engineering file review
- Software documentation package for submission
- Deficiency letter responses
How I help
Design controls
Design and development planning, inputs, outputs, reviews, verification, validation, transfer and change control, mapped cleanly to your software lifecycle.
QMSR and ISO 13485
Gap assessments against ISO 13485:2016 and FDA's QMSR additions, procedure updates, and internal audits run to lead-auditor standard.
Usability engineering
Use specifications, critical tasks and hazard-related use scenarios tied into the risk file, and review of human factors reports before submission.
Submission documentation
Documentation level decisions (Basic vs Enhanced), pre-submission gap reviews, and responses to additional information requests.
Case study
Launching a new interventional laser system and its EU MDR file at the same time
The fault tree showed empirically that the software didn't add risk to the device, answering FDA's question with data instead of argument.
Read the case study →How engagements work
Most work starts with a short call and a fixed-scope assessment, then moves to a project or a monthly retainer. I work remotely, with on-site time when it helps; travel is billed as set out in the engagement agreement.
Related guides: QMSR (21 CFR 820) · IEC 62366-1 · FDA software guidance
Other capability areas
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.
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.