TURNING REGULATION
INTO SUCCESS
Discover Our Amazing Free Tools
Creating an MDR/IVDR conform Declaration of Conformity in under 5 minutes? Determining the risk class of your device without loosing your nerves? Deciding if you can use the same Basic UDI-DI for different devices without reading hundreds of pages? Prepare a precise intended purpose statement as a great base for your Technical Documentation?
Everything is possible with our amazing free tools!
Everything is possible with our amazing free tools!
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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.