Our medical device experts provide pragmatic and goal-oriented help. We are experts in our field, so we speak your language. You can expect competent help on topics related to MDR, IVDR and other regulatory frameworks.
Our focus: Digitalization of Technical Documentation, Clinical Evaluation, Performance Evaluation, Post-Market Surveillance, EUDAMED and UDI.
A selection of our services
Digitalization of Technical Documentation
Automation of Technical Documentation
Automation of CER, PSUR, SSCP
Strategic Digital MDR and IVDR Project Consulting
Preparation of Digital Clinical Evaluations
Setting up Digital PMS and PMCF Projects
EUDAMED Data Management
Digital Label & IFU Management
and much more
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The fastest and easiest way to digitalize your RA & QA
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