Workshops – Build Internal Expertise for Clinical Evaluation & PMCF
MDR training shouldn't just repeat regulations — it should give your team practical skills they can apply immediately. I offer interactive workshops tailored to your devices and processes, combining expert training with hands-on exercises. Your team learns how to produce clear, compliant documentation efficiently and independently.
Interactive and practical workshops tailored to your needs
Each workshop is customized to your team's needs and current processes. I combine regulatory training with real-world examples and hands-on exercises, so your team can apply their learnings right away.
Training that actually strengthens internal competence
Clinical Evaluation and PMCF requirements under the MDR can be complex, and many teams struggle with inconsistent processes, outdated templates, or a lack of internal expertise. Many training sessions just repeat what is written in the regulations and guidelines, but don’t offer practical tips.
Interactive workshops tailored to your devices and processes
I offer interactive workshops that combine expert training with hands-on exercises to strengthen your team’s regulatory competence. Each workshop is tailored to your specific devices, processes, and documentation needs. Together, we review your current templates and internal workflows, identify areas for improvement, and develop more transparent, efficient processes that align with MDR expectations. Your team learns not only what to do — but how to apply it immediately in practice.
Workshop topics
Depending on your needs, you can select or combine workshops on:
Clinical Evaluation under the MDR
PMCF strategies and documentation
State-of-the-Art evaluations
SSCP preparation and structure
Medical Device Software incl. AI/ML devices
Good Medical Writing Practice
Fully tailored agendas adapted to your team and your devices
Each workshop includes practical exercises, interactive discussions, examples from real-world projects, and optional review and optimization of your internal templates and processes.
A team that produces compliant documentation independently
Your team gains the confidence and skills to produce clear, MDR-compliant documentation, independently and efficiently. These workshops not only increase knowledge — they transform the way your organization works with clinical evidence and regulatory documentation.
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 than100 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.