Gap Analysis & Audit Preparation
In detail
A gap analysis is a structured assessment of your current QMS against the applicable regulatory requirements, with clear action plans as the result. Risk management per ISO 14971:2019 is part of that assessment: systematic hazard identification, risk estimation and evaluation, risk control measures and residual risk assessment. My background in aviation engineering shapes the approach — aviation and medical devices share the same non-negotiable: when systems fail, lives are at stake.
Gap Analysis
Structured assessment of your current QMS against regulatory requirements — clear action plans.
Internal Audits
Thorough, systematic internal audits to identify gaps, ensure compliance, and prepare your organization for external certification audits.
Can you help us prepare for a specific audit or inspection?
Yes. Audit preparation is one of the most time-sensitive QMS challenges a company faces. I can step in to conduct a thorough internal audit, identify gaps against the applicable standard, prioritize corrective actions, and prepare your team for the audit process — whether it's a notified body audit, a customer qualification audit, or an FDA inspection. The earlier I'm involved, the better the outcome.
What does CAPA management involve and why does it matter?
CAPA stands for Corrective and Preventive Actions. It is the engine of a functioning QMS: when something goes wrong — a non-conformity, a complaint, an audit finding — CAPA ensures the root cause is identified, addressed, and prevented from recurring. Regulators look closely at CAPA systems because a weak CAPA process is a strong indicator of a weak quality culture. A well-run CAPA system turns problems into permanent improvements.