Clinical Evaluation –
From strategy to MDR-compliant documentation
Establishing a robust clinical evaluation under MDR can feel overwhelming. I remove the complexity and give you a clear, efficient path forward. With over 50 completed projects, I help you build defensible clinical evidence that passes Notified Body review without delays or major findings.
4-step process
I follow a systematic approach for each project. Each step builds logically on the previous one, ensuring your Clinical Evaluation is complete, defensible, and aligned with regulatory expectations.
Strategy & planning – Define the right clinical pathway
Many medical device manufacturers struggle with unclear strategies for the clinical evaluation, inconsistent documentation, and uncertainty about whether their clinical evidence is sufficient. Missing structure, outdated templates, or unclear roles can delay submissions and put market access at risk.
Build a robust foundation – Establish the State-of-the-Art
I apply a proven, efficient system to develop a strong clinical evaluation strategy tailored to your device. I will build a solid State-of-the-Art foundation, assess all available clinical data, identify evidence gaps, and define the most cost-effective pathway to close them. With lean processes, consistent templates, and clear communication, I help you create compliant, reviewer-friendly documentation without unnecessary workload.
Documentation & reporting – Submission-ready files
You receive all essential documents for a complete, MDR-compliant Clinical Evaluation:
Clinical Development Plan
Clinical Evaluation Plan
Literature Search Plan and Report
State-of-the-Art Evaluation
Clinical Evaluation Report
Robust documents with minimal maintenance
You gain a clear, defensible Clinical Evaluation package that Notified Bodies can easily follow. My clients consistently benefit from:
Smooth NB reviews with no major findings
Reduced internal workload thanks to lean, logical structures
Faster submissions and shorter review cycles
Confidence that the clinical evidence is strong, compliant, and aligned with the current State of the Art
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 Notified Body 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.