Turning regulation into success

Something new is taking shape

At AstraCon, we believe regulatory work shouldn’t feel overwhelming. That’s why we are developing cevvy: a new way of handling technical documentation. It helps you focus on what really matters by showing only what’s relevant to your product and guiding you through each step with clarity and structure. We’re genuinely excited ourselves and can’t wait to use cevvy for our own work. Join us on our journey and be among the first to experience a simpler, more mindful way to create technical documentation.

Visit cevvy

NEW

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.

AstraTools

Creating a 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!

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.

Stay Informed

Stay informed about regulatory developments, product updates, and best practices for digital technical documentation.