Ngwarati Consulting
Resilient by Nature. Innovative by Choice.
Clinical evaluation expertise and AI-enabled workflows for medical device manufacturers navigating EU MDR and IVDR — built by someone who has actually written the reports.
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About
I grew up in Zimbabwe until I was 16. I did my PhD on malaria vaccines — because I thought science would be my way back to Africa. The parasite had other ideas.
So I built a career in medical device regulation in Germany instead. 7+ years of EU MDR and IVDR — clinical evaluation, IVD performance evaluation, clinical trial management.
Alongside my regulatory work, I started building tools to solve problems I kept encountering in clinical evaluation. That became COBRA.
COBRA gives you your thinking time back.
Fear obscures. Clarity moves.
What I do
Clinical Evaluation Plans and Reports across all EU MDR pathways. Claims analysis, strategic planning, literature search, SOTA, PMCF — the full evidence spectrum for Class I–III devices.
Analytical and clinical performance evaluation per IVDR. CLSI-guideline conform experimental design. Scientific validity documentation. Performance Evaluation Plans and Reports.
COBRA — AI-powered clinical evaluation platform. Strategic AI consulting and team training. The DIRIGE framework for working with AI, not just using it.
The Platform
Clinical Outcomes Based Research Assistant. Not a search tool. Not a screening tool.
"A writing desk — built by someone who has actually written these reports."
COBRA covers the full pipeline: search strategy generation, literature retrieval, abstract analysis, and a structured writing desk with annotated Post-Its, gap analysis, and writing tips — purpose-built for CER and IVDR authoring.
A tool that works for everything works well for nothing.
The name
Ngwarati is the Shona word for sable antelope — one of Africa's most striking animals. Known for resilience, precision, and quiet strength. It moves with purpose and does not need to announce itself.
That is the philosophy behind this work. Deep expertise, delivered with clarity. No noise. Just results.
Contact
Whether you need a clinical evaluation strategy, IVDR support, or want to know what COBRA can do for your team — reach out.