Medtech and diagnostics teams need evidence and narratives that translate study results into submission-ready texts and adoption-ready communications. Assignments focus on clinical and performance evaluation, submission narratives for EU MDR/IVDR and U.S. FDA routes, post-market documentation, and publication-grade manuscripts that support uptake without overstating certainty. Materials are written in English and shaped so regulatory reviewers, technical file owners, clinicians, and commercial stakeholders can all use the same documents.
For the EU, clinical and performance evaluation reports are prepared to MDR/IVDR expectations with consistent terminology, traceable links to study records, and explicit appraisal of clinical/performance data quality. General Safety and Performance Requirements are mapped to evidence with gaps and mitigations stated. Post-market surveillance and PMCF/PMPF plans and reports are drafted with clear objectives, data sources, trigger thresholds, and responsibilities so notified bodies can follow the logic. Risk management language aligns with ISO 14971; usability narratives reference IEC 62366 where applicable; software sections can reflect IEC 62304 and relevant cybersecurity guidance for networked or AI-enabled functions.
For the U.S., submission narratives are written for the intended route—510(k), De Novo, or PMA—with predicate or reference device logic presented plainly and performance claims bounded by the data. Study descriptions, acceptance criteria, and results are reconciled across text and tables; assumptions are explicit so FDA reviewers can navigate quickly. Labeling language is consistent across IFU, marketing copy, and risk materials, and UDI and device identification details are handled cleanly.
Evidence handling follows protocolled steps when justified. Search strategies, selection rules, and extraction templates are documented; conclusions are tied to effect direction and strength rather than implied certainty. For diagnostics, performance is framed with the measures that matter—sensitivity, specificity, likelihood ratios, agreement—and study limitations are stated where they affect use. Figures and tables are built from verifiable data, legends stand alone, and supplementary files let reviewers trace values to origin.
Operational delivery is predictable. Draft one arrives on the scheduled date with tracked changes and a comment log explaining key decisions and references. One focused revision round is included to close open questions. Handover includes submission-ready files, editable vector figures, and a managed bibliography that slots into technical documentation and publishing workflows. Confidential material is handled under NDA with encrypted transfer, named-user access, and retention limited to the period specified in the statement of work. Assignments are executed in English for organisations across Europe and beyond, with contracting and invoicing available in CHF, EUR, NOK, or DKK.