Quality Assurance • Regulatory Affairs • Consulting

Selected projects across multiple professional domains.

These projects are some of my favorites over my experiences of over two decades.

I love playing with different scenarios giving tough times to the application under development.

Regulatory • ISO 13485

ISO 13485 QMS Refresh & Audit Readiness

Conducted a thorough review and update of the QMS-documents - including SOPs, WIs, QPs, QMs and forms to remain in alignment across the device lifecycle.

Mapped real workflows to procedures to eliminate gaps and outdated steps.
Improved linkage between SOPs, records, risk files, and CAPA pathways.
Supported internal audit readiness and assessment of previous CAPAs.

Health Canada QMS ISO 13485 Internal Audit

Regulatory • EU MDR

Transition from MDD to MDR

Supported the transition of technical files from MDD to MDR for a range of devices. Updated risk templates, traceability matrices, and document structures to reflect MDR expectations.

Mapped existing documentation to MDR Annexes and key articles.
Enhanced risk evaluation criteria and post-market feedback loops.
Aligned terminology and structure across cross-functional documents.

EU MDR Technical File Risk Management

Have a project or idea in mind?

Whether you’re building a medical device product, validating a complex platform, or designing support for international graduates in QA, I’d love to explore it with you.

Let’s discuss