Post-Market Clinical Follow-Up (PMCF) – Find the right strategy for your device
PMCF is not optional under MDR — but defining the right activities can be challenging. I help you build efficient, defensible PMCF strategies tailored to your device. From literature reviews and user surveys to registries and real-world evidence, you get targeted approaches that close evidence gaps without unnecessary workload.
4-step process
I follow a systematic approach that connects your Clinical Evaluation outcomes with the right PMCF activities. Each step ensures your PMCF Plan is defensible, proportionate, and aligned with MDR requirements.
Identifying the right PMCF activities for your device
PMCF is a core requirement under the MDR. Many manufacturers struggle to define meaningful PMCF activities, choose the right data sources, or justify why certain activities are sufficient. Without a clear strategy, teams risk inefficient plans, excessive workload, or Notified Body findings questioning the adequacy of their post-market evidence.
Tailored PMCF strategies to close gaps in clinical evidence
I develop PMCF strategies that are compliant, efficient, and tailored to your device. Based on the outcomes of your Clinical Evaluation, I identify evidence gaps and select the most appropriate activities to close them — from structured literature reviews to user surveys, device registries, PMCF studies, or real-world evidence (RWE) approaches.
Complete PMCF documentation
Your customized PMCF package can include:
PMCF Plan
Targeted literature reviews (SOTA updates, long-term safety, performance trends)
User surveys (design and analysis)
Registry strategies (using existing registries or building fit-for-purpose solutions by protocol support)
PMCF Investigations (study concept, protocol support)
Real-world evidence strategies (datasets, methodology, integration into CER and PMS)
PMCF Evaluation Report
Robust PMCF strategy that meets MDR requirements
You receive a robust, defensible PMCF strategy that meets MDR requirements and strengthens the clinical evidence for your device, without overburdening your team.
With extensive experience implementing PMCF activities, from literature reviews and surveys to registries and real-world evidence, I help manufacturers collect meaningful clinical data efficiently.
A strategic partner – Not a generic consultant.
Many regulatory consultants rely on generic templates and high-level summaries. I take a different approach: combining medical expertise, scientific knowledge, and a deep understanding of MDR requirements to create documentation that meet NotifiedBody expectations. I deliver clear, well-structured files for efficient reviews, fewer questions, and smoother approvals.
Working with me
Tailored clinical strategies instead of one-size-fits-all templates – Every device is different. I develop Clinical Evaluation strategies based on your device’s risk class, intended purpose, clinical context, and available evidence.
Clear, reviewer-friendly documentation – I structure Clinical Evaluation documentation so it is easy to follow and logically consistent. Clear argumentation and strong links between CER, PMCF, SOTA, PMS, and risk management help Notified Bodies understand and assess your files efficiently.
Regulatory knowledge grounded in 100+ projects – With experience from more than 100 Clinical Evaluation projects, I bring strong medical writing skills, evidence-based reasoning, and hands-on knowledge across device types and risk classes.
Lean processes that reduce your internal workload – I help streamline templates, terminology, and workflows to make clinical documentation manageable over time, allowing your team to focus on development, innovation, and day-to-day business.