How We Work
How We Turn Evidence Into Clear MDR Documentation
A structured, transparent process — from documentation triage through to final delivery of audit-ready documents.
Documentation Triage
We review the project objective, device type, MDR classification, current documentation status, timelines, and any Notified Body comments. We establish what exists, what is missing, and what the deliverable is.
Evidence and Gap Mapping
We identify where clinical, PMS, PMCF, risk, claims, literature, and benefit-risk evidence is missing, weak, inconsistent, or poorly connected. This forms the basis of the writing strategy.
Writing Strategy
We define the documents, sections, response tables, and evidence narratives required to address the project goal. For multi-document projects, we agree a delivery sequence and review workflow.
Regulatory Writing
We draft or remediate CER, PMS, PMCF, PSUR, SSCP, or response documentation using clear structure and reviewer-friendly logic. Drafts are provided for your team's review and feedback.
Cross-Document Consistency Check
We check alignment across intended purpose, claims, risk management, clinical evidence, PMS/PMCF outputs, and benefit-risk conclusions. Inconsistencies are flagged and resolved before final delivery.
Final Delivery
You receive clean, structured, review-ready documents or response packages with clear traceability and revision rationale. For ongoing projects, we set up a documentation update schedule.
How We Collaborate
We work as an extension of your regulatory team — structured, transparent, and clear about scope.
We work to your timeline
We are direct about what is achievable within your deadline. For Notified Body response windows, we prioritise accordingly.
We work with your team
We need input from your RA/QA, clinical, and technical teams. We make that collaboration structured and efficient rather than open-ended.
We document our decisions
Every writing decision, gap, or deviation is logged so your team and auditors can follow the rationale.
We do not substitute for your regulatory expertise
We are writers and regulatory specialists. Final regulatory decisions remain with your responsible person or regulatory affairs lead.
Ready to Start With a Gap Review?
A Documentation Gap Review is the fastest way to understand scope, priorities, and what comes next.