TURNING REGULATION INTO SUCCESS
NEW!!! Our Amazing Classification Tool AstraClass
With just a few clicks, our tool will determine the risk class of your device. It even tells you, which rule of the MDR/IVDR applies to your device.
Technical Documentation
We review or create selected documents or the complete technical documentation of your medical device or IVD product. Thereby, we ensure that they are MDR or IVDR compliant.
QM System (ISO 13485)
Set up your QMS by using our templates, our input, our hands-on-help or let us do (nearly) all of the work. Whichever way you choose, we will get your QMS audit-ready.
Regulatory Consulting
Come to us with your questions. We offer answers and solutions for topics related to regulations, standards, QMS, strategic decisions, CE marking, or market access.
Templates
Use our templates full of helpful guidance to create your Technical Documentation or your QMS. Save even more time with pre-filled, individualized templates with your logo.
