Post-Market Clinical Roadmap
EU-MDR post-market obligations require a coherent strategy — not isolated documents. I build integrated post-market systems anchored to a claims matrix that connects every deliverable to your actual evidence base.
The Problem
Most companies treat post-market clinical obligations as isolated compliance tasks: the CER is written by one consultant, the PMCF plan by another, the vigilance SOPs by a third. The result is a set of documents that technically exist but do not form a coherent system — claims are not traced to evidence, PMCF activities are not linked to identified gaps, and vigilance processes operate independently of the clinical evaluation.
Notified body auditors see through this immediately. More importantly, a disconnected post-market system fails at its actual purpose: ensuring that your device remains safe and that your clinical claims remain substantiated as new evidence accumulates.
My Approach: The Claims Matrix
Every post-market engagement starts with a claims matrix: a structured mapping of your technical, clinical, and regulatory claims against the evidence that supports each one. This reveals where your evidence is strong, where gaps exist, and what activities are needed to close them.
Every subsequent deliverable — from the CER to the PMCF plan to the vigilance SOP — follows from this analysis. The claims matrix is the backbone that connects all post-market activities into a single, auditable system.
This is not a template-based approach. Each claims matrix is built from your actual device, your actual indications, your actual evidence, and your actual regulatory commitments.
Service Catalog
Claims Matrix Development
Systematic mapping of all technical, clinical, and regulatory claims for your device against the evidence that supports each claim. The matrix identifies evidence gaps, assigns risk levels, and defines the activities needed to close each gap. This document becomes the master reference for all subsequent post-market deliverables and is updated with each CER cycle.
Clinical Evaluation Plans & Reports (CEP/CER)
Complete clinical evaluation documentation per MDR Annex XIV, MEDDEV 2.7/1 Rev. 4, and applicable MDCG guidance. The CEP defines the evaluation scope, literature search strategy, appraisal criteria, and clinical data sources. The CER presents the full clinical evaluation: device description, state of the art, clinical data analysis, equivalence assessment (if applicable), benefit-risk determination, and conclusions on conformity with the General Safety and Performance Requirements (GSPR). Each CER is directly traceable to the claims matrix.
PMCF Plans, Evaluation Reports & Surveys
End-to-end PMCF documentation: from the PMCF Plan (defining objectives, methods, and timelines) through PMCF study or survey design (including protocol development, questionnaire design, and statistical analysis plan) to the PMCF Evaluation Report summarizing findings and their impact on the clinical evaluation. PMCF activities are designed to address specific gaps identified in the claims matrix — not generic data collection exercises.
Post-Market Surveillance Strategy
Development of a PMS strategy that integrates complaint handling, trend analysis, literature monitoring, and registry data into a coherent system. The PMS plan defines data sources, collection methods, analysis triggers, and reporting timelines. Integrated with risk management per ISO 14971 to ensure that post-market data feeds back into the risk-benefit assessment.
Signal-to-Action Process
Design and documentation of the complete signal detection and response pathway: from the identification of safety signals in clinical studies, complaint databases, and literature through PRRC assessment and decision-making to authority reporting (serious incident reports, field safety corrective actions, trend reports, periodic safety update reports). Clear escalation criteria, defined responsibilities, and documented decision rationale at every step.
Vigilance SOPs
Standard Operating Procedures for vigilance reporting compliant with MDR Articles 87–89. Covers serious incident reporting timelines, field safety corrective action procedures, trend reporting obligations, and periodic safety update reports (PSUR). Each SOP includes process flowcharts, form templates, and clear assignment of responsibilities.
Complete Clinical Research SOP Systems
Development of full SOP systems covering clinical research operations under ISO 14155, EU-MDR Chapter VI, 21 CFR 812, and ICH E6(R2)/GCP. This includes SOPs for study initiation, monitoring, data management, safety reporting, study close-out, and document control. Designed to be practical and implementable — not shelf documents that satisfy an audit checklist but are never used in practice.
Regulatory Framework
All post-market services are delivered in compliance with:
- EU Medical Device Regulation (EU) 2017/745 — Annex XIV, Chapter VII
- MEDDEV 2.7/1 Rev. 4 — Clinical evaluation guidance
- MDCG 2020-7, 2020-8, 2020-13 — PMCF and clinical evaluation guidance
- ISO 14971 — Application of risk management to medical devices
- ISO 14155 — Clinical investigation of medical devices
- 21 CFR 812 — Investigational Device Exemptions (FDA)
- ICH E6(R2) — Good Clinical Practice
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