Turning regulation into success

Your notified Buddy

The notified body MDR review is coming up and failure is not an option? But you heard that most of the submissions are incomplete. And you fear that your technical documentation might not pass the test?

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?

NEW

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.

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.