Über mich
I have always found the new – even the new in the existing – as well as people’s personal growth fascinating, whether skills or interests, professionally or privately. To dare to do something new and to free oneself from other people’s or, above all, one’s own limitations. In our highly regulated business environment, it is becoming increasingly difficult and time consuming to bring new ideas to market. I support entrepreneurs to become „industry-ready“ and to let their ideas grow into reality.
Ask me about:
Approvals of (medical) devices and CE marking in general; Medical Device Regulation, MDR (EU); Good Manufacturing Practice, GMP (21 CFR 820, FDA); Quality Management Systems – ISO9001 and ISO13485; Risk Management Systems – ISO14971; General Data Protection Regulation – GDPR; Information security – ISO27001 and HIPAA-Compliance; Process control and optimization
What I can offer:
1:1 for MedTech startups – compact, hands-on introduction for all teams that are (perhaps for the first time) dealing with regulatory approval. I explain what a medical device legally means, what obligations come with it – and how startups can stay on top of things as well as realistically estimate the effort involved.