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.

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UNTIL IVDR