Turning regulation into success
Your notified Buddy
Your Notified Buddy is here to help you and he has a plan:
1. He searches for the biggest bugs and gaps.
2. He shows you how to fix them, or does the fixing for you.
3. He makes sure that everything is ready for your successful MDR certification in time.
You would like his help and save valuable time and money, better spent on something worth your expertise?
AstraTools
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!
Legal Representative
You are planning to conduct a performance study according to IVDR (EU) 2017/746 in one or more countries of the Union? In this case, you need a legal representative who is responsible for ensuring compliance with your obligations under the IVDR and acts as a contact on your behalf (IVDR Article 58). AstraCon can take over these obligations. If needed, we can also support you in planning and executing your submission strategy.
Technical Documentation
We review or create selected documents or complete technical documentations of medical devices or IVD products. 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.