Backed by an engineering PhD and years of experience across MedTech and healthcare, I help teams adapt their existing structures, introduce only the controls and records they actually need, and keep staff training practical and focused. My mission is to help companies achieve sustainable governance and audit-ready documentation without unnecessary complexity or reporting burden.
A MedTech lead preparing or updating a CER, PMS, PMCF, or any other technical documentation file, needing reliable support in clinical evidence and solid argument and someone that can immediately plug into your workflow.
A software, diagnostics, imaging, or connected-device team working with patient data, clinical outputs, or AI-assisted workflows and needing lightweight documentation that shows how tools, data, outputs, and human review are controlled.
A medical affairs team lead asked to show how AI governance and quality are being built in clinical, regulatory, or medical writing work, needing audit-friendly AI-use records but wanting a practical system, instead of a giant policy binder.
When adapting to AI governance requirements or medical device regulatory updates, large-scale changes can create unnecessary costs and complexity. We help organizations identify the smallest effective changes: adapting existing structures where possible, updating only what is necessary, and keeping staff training focused and practical.
Verifying evidence and interprecation with strong critical reasoning, so your regulatory documentation is defensible before authorities.
Turning fragmented legal, technical, quality, and business requirements into a practical, centralized and auditable governance system.
Practical training on evidence verification and critical thinking while using AI to enhance accuracy in writing.
Cross-functional expertise: I connect the needs of different teams and apply critical thinking across AI governance, regulatory documentation, and related business functions.
Fast, client-focused adaptability: I quickly understand what clients and stakeholders need and adjust my approach throughout the project.
Strong root-cause analysis: I identify real underlying issues across functions, helping teams coordinate effectively, solve problems, and keep projects moving forward.
“Ri worked quickly, interacted with various stakeholders in the project and demonstrated flexibility in her approach and willingness to go into details to assure alignment between different stakeholders. Ri set up meetings and followed up with the team to gather the information, which was much appreciated. Ri’s communication was typically very fast and her questions and comments were clear. Ri brings cross-functional expertise and adapts readily to the practical needs of a project, contributing beyond her core writing and QA responsibilities when additional support is needed. Ri was very open to suggestions or requests for change, and easy to work with.”
Ri Xu, PhD provides clinical evidence, CER support, fact-checking, and AI governance documentation for MedTech companies and medical writing teams. Her work helps regulated teams keep evidence, data summaries, AI-assisted workflows, and review records clear, traceable, and defensible in environments where small errors can create regulatory, clinical, or audit risk.
Based in Montreal and working internationally, Ri partners with RA/QA, clinical affairs, medical writing, product, and innovation teams to turn complex clinical, regulatory, and AI-related information into practical documentation. Backed by an engineering PhD, medical writing experience, and AI governance training, she helps teams strengthen accuracy, reduce documentation friction, and use AI critically without compromising evidence standards.