Medical device quality consulting
I've worked inside an ISO 13485 manufacturing operation - managing design transfers, running CAPA investigations, and qualifying suppliers for IVD diagnostics.
The challenge
Medical device manufacturers face a shifting regulatory landscape. QMSR took effect in February 2026, incorporating ISO 13485 by reference and making supplier audit reports directly inspectable by FDA. Design transfer documentation gaps that were tolerable before now carry real inspection risk. And as supply chains get more complex, supplier qualification programs that grew organically need formalization.
Why me
At Luminex Corporation (now DiaSorin), I worked in ISO 13485 reagent manufacturing under 21 CFR Part 820. I managed design transfers of life sciences instruments into manufacturing, led data-driven CAPA investigations that resolved recurring equipment and process failures, and drove process automation improvements. I know what these quality systems look like from the inside, not from a consultant's desk.
How I help
Supplier qualification
ISO 13485-compliant supplier programs. Assessments, quality agreements, specifications, and monitoring.
Design transfer support
Documentation for moving designs into manufacturing. Specs, procedures, validation, acceptance criteria.
CAPA & deviation management
Investigation support, root cause analysis, corrective actions, and process improvements.
QMSR transition
Gap assessment of your QMS against new QMSR requirements. What changed, what needs updating.
Quality system assessments
Gap analysis against ISO 13485, 21 CFR 820, and QMSR. Prioritized remediation plans.