As a licensed physician and certified Lead Auditor for DIN EN ISO 13485, I reliably guide companies from the first draft through to CE marking – and beyond.
My career began in the clinic – as a licensed physician focused on patients, diagnoses and therapeutic outcomes. I bring this medical expertise directly into regulatory work today: I do not merely assess medical devices formally, but understand how they function in everyday clinical practice.
As a certified Lead Auditor for DIN EN ISO 13485, I audit quality management systems and advise companies on the design, optimisation and certification of their QMS structures. Working independently, I am a reliable partner for start-ups and small to mid-sized medical device companies.
Whether clinical evaluation, audit activities or interim management as QMR – I bring expertise that goes beyond the purely formal.
From clinical evaluation and quality management through to interim management – a complete range of services from a single source.
Advice on optimal classification, approval routes and efficient resource use in the CE process.
Advisory and evaluation services for the use of artificial intelligence and large language models (LLMs) in medical devices – from regulatory to clinical validation.
Creation and updating of clinical evaluation reports per MDR Annex XIV, including literature review and equivalence assessment.
Temporary assumption of management functions – e.g. as Quality Management Representative (QMR) or head of Regulatory Affairs during vacancies or projects.
Design and implementation of quality management systems per DIN EN ISO 13485 – from planning through to certification readiness.
Systematic gap analysis of your documentation and targeted preparation for audits by Notified Bodies and the FDA.
Creation and review of risk management systems per ISO 14971, including risk mitigation and its validation.
Planning, execution and documentation of process qualifications (IQ/OQ/PQ) per regulatory requirements for manufacturing and test processes.
Creation and review of technical documentation per MDR Annex II and III – complete and Notified Body-ready (also AI-readable).
Design and implementation of Post-Market Surveillance and Post-Market Clinical Follow-up plans for sustained clinical oversight per MDR.
Clear steps, transparent communication and lasting results – that is how we work together.
Free-of-charge needs analysis and assessment of your regulatory situation.
Systematic review of your documentation against MDR and ISO requirements.
Creation of all documents in close coordination with your team.
Support through to the Declaration of Conformity and successful market launch.
Continuous assistance with PMCF, vigilance, audits and regulatory updates.
A selection of completed projects – further details available upon request.
A mid-sized mechanical engineering firm required a clear regulatory roadmap for a negative-pressure therapy device: product classification, conformity route, QMS setup and document control. Following workshops, a gap analysis and a structured milestone plan with budget estimates, the company was able to independently begin building its QMS.
Integrating AI – particularly LLMs – into medical devices requires building a team with clinical expertise and IT know-how early on to ensure data quality and validity during AI training. My support includes strategic advisory, clinical data quality assurance, audits, clinical evaluations, product qualifications, and Post-Market Surveillance and PMCF.
Creation of clinical evaluations for Class I to III products, including hip and spinal implants, intraoperative aids in angiology, drug delivery pens, CDSS software, apps (SaMD) and various aids per MDR 2017/745.
Building a complete quality management system per DIN EN ISO 13485 for a start-up – from kick-off through to successful initial certification.
Full gap analysis, revision of technical documentation per MDR Annex II/III, creation of the clinical evaluation and successful audit preparation.
Assumption of the QMR role during a personnel vacancy. Maintenance of the QMS, conduct of internal audits, and successful management of the surveillance audit and FDA inspection.
Are you planning a CE conformity procedure or need support with the clinical evaluation of your medical device? I look forward to hearing from you.
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