How can we help?


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.

Technical Documentation

We review or create selected documents or complete technical documentationd 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.

Legal Representative

You want to conduct a performance study according to  IVDR but your company is not established in the Union? We can take on the role as legal representative for you.


Individualized for you!

Creating the Technical Documentation for your medical device or IVD product can be a complicated and time-consuming affair. It doesn’t have to be: we offer you templates with guidance. What’s more, we offer individualized templates. Overall, this AstraCon unique feature allows you to finalize your documents even quicker.


Let us do the work for you!

Technical Documentation - Gap Analysis

A quick check for manufacturers, investors, and EC representatives!

Many stakeholders are unsure about the quality and completeness of the Technical Documentation. Since the Technical Documentation is the regulatory heart of your medical device or IVD product (MDR/IVDR), you need to know about all the gaps. Our GAP analysis will give you a comprehensive overview. This will enable you to focus on the biggest issues and gaps.

This is not only important if you are a manufacturer and therefore in the possession of your own Technical Documentation. It might also be important, if you are an investor or EC representative and you are unsure, if the quality of the documentation of your partner company is sufficient.

Technical Documentation - Review

Sometimes, however, a quick check might not be enough for your purposes. Instead, you may need a detailed MDR or IVDR compliance check. In this case, a document review performed by our experts might me a better option. During the review process, our experts will check if all requirements of MDR/IVDR regulations, from applicable harmonized standards, as well as acknowledged guidance documents are fulfilled. This will enable you to get your documentation Audit-ready quickly and efficiently.

Technical Documentation - Creation

You need Technical Documentation for your EU market launch? Whether individual documents or the entire Technical Documentation: our experts work quickly, reliably and ensure the highest quality. Audit-ready documents are created in close consultation with you.


Get started today!

QMS - Review

Your QMS is out-dated, an audit is coming up, or you are unsure if it is ISO 13485 compliant? Our experts will do a thorough compliance check of single documents or your complete QMS. Our experts will review your documents (especially your QM manual and the top level documents like SOPs) and provide a detailed assessment considering the latest harmonized standards and regulations. With our guidance, you will have your documents audit-ready in no time.

QMS - Creation

Your company needs a functional quality management system? However, you lack the time and resources to build your own QM system. Then, let our experts support you in reviewing or creating your QM system. Whether individual documents or the entire QM system: our experts work quickly, reliably and ensure the highest quality. Audit-ready documents are created in close consultation with you.

QMS - Internal Audit

You need to know if the QM system is audit-ready? In this case, we conduct ISO 13485 conform internal audits for you at your company or on your suppliers’ premises. Our qualified auditors prepare all the necessary documentation required for a successful audit: Audit plan, audit agenda and of course the audit report.


Not sure how to find your way
to ISO 13485 Certification, CE Marking and EU Market Access?

Answers to your Regulatory Questions

Understanding and acting efficiently on regulations like MDR and IVDR is often complicated. Like a mountain guide, our experts will guide you to the top of the regulatory mountain, according to your individual needs and skill sets. Particularly, they will answer all your questions in the best possible way and thereby help you find the most relaxing, safest, fastest, shortest or most instructive regulatory route. You can count on our answers to bring you closer to your goal – ISO 13485 certification or CE marking and market approval of your IVD or medical device.

Selection of and Communicaton with Notified Bodies

The selection of a Notified Body is an important step on your way to CE, especially in times of low audit and review capacities at Notified Bodies. We can support you in selecting a suitable Notified Body – taking into account your company-wide regulatory strategy. In addition, we can take over the communication with the Notified Body completely for you. Of course, the clarification of non-conformities with you is also part of our portfolio.

Legal Representative

for your EU Performance Studies.

Legal Representative for EU Performance Studies

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 persuant to IVDR and who acts as a contact on your behalf (IVDR Article 58). AstraCon can take those responsibilities on. If needed, we can also support you in planning and executing your submission strategy.






ISO 13485


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