Faster to market with regulatory expertise for medical devices
We are regulatory affairs experts for medical devices. With our highly-qualified team of German and English-speaking PhD scientists we stand for short-term, flexible, individual and professional project management and handlingto bring your products faster to market or keeptheir approval. Practical industry experience, up-to-date experienced-based knowhow enable us to support you very efficiently and pragmatically in creating the necessary documentation for your products and processes.
You will receive individual support and advice. With our broad expertise, we are a reliable partner for a wide range of companies, from startups to DAX-listed corporations.
We provide guidance for all risk classes including in-vitro diagnostics and active medical devices. With our work we aim for a CE certificate or international approval for your medical device, or a quality management system according to ISO 13485.
YES Your External Support!