We think: Creating Technical Documentation is fun! Unfortunately, our customers often see it quite differently. That’s why we met secretly and worked on new ideas in our AstraCon tool shed. The results are great tools that we are happy to make available to you, dear customer, free of charge. And why? So that you too can finally understand why it can be so much fun to create a Technical Documentation.
Declaration of Conformity Generator
Create a MDR/IVDR conform Declaration of Conformity for your devices. Use it for free and as many times as you like. Use the tool, copy the content,
sign your DoC.
Determine the risk class of your medical device now! The tool will guide you through a series of questions. At the end of which you will know the classification of your device.
Build the foundation for your Technical Documentation by generating your intended purpose statement. Try our generator and use it throughout your Technical Documentation.
This little tool will help you to determine if you need to introduce a new Basic UDI-DI for your device or if you can use an already existing one from another product of yours.
This marvellous tool will help you to determine if a change to your product is considered significant according to transitional provision of Article 120(3) MDR.
AstraDoc – the Declaration of Conformity Generator
You as the manufacturer of a medical device or IVD medical device hold the power to declare the conformity with the applicable EU regulation (MDR or IVDR). To sign the final document – the declaration of conformity (DoC) – is a very special moment for you and your device. You are finally allowed to apply the CE mark and conquer the European market. But are you really sure, that this important document is conform to the regulation as well? Because you will not only show your DoC to authorities, but also to distributors and customers. With the DoC Generator you are now able to create an MDR/IVDR conform DoC in less than five minutes. As always for free. Get out your stop watch and start typing.
AstraClass – the Classification Tool
The risk class of your medical device or IVD product determines the regulatory requirements you will have to deal with. For instance, whether or not you need to undergo a Notified Body Conformity assessment. So, classifying your product correctly is absolutely essential. However, this basic step is often done wrong. No wonder – it is exhausting and confusing to work through all the classification rules of the MDR/IVDR. We are therefore particularly pleased to be able to make this difficult and complex work immensely easier for you: with our unique, free classification tool “AstraClass”, classification is finally a lot of fun. We ourselves use the tool almost daily in our work. Just try it out and prepare yourself to be amazed!
AstraPurpose – the Intended Purpose Generator
The intended purpose is like the foundation on which your Technical Documentation (your house) is built. If it wobbles, the whole house will soon collapse. On the other hand, you will benefit from a precisely formulated intended purpose. The clearer you are about what claims you want to prove, the easier it will be for you to create your documents. Just think about the clinical evaluation, performance evaluation, literature search strategy, or PMS documents. Here, we provide you with a great new tool: our free intended purpose generator “AstraPurpose”. Generate your intended purpose statement conveniently with just a few clicks.
AstraBUDI – the Basic UDI-DI Decision Tool
Are you wondering whether you need to create a new Basic UDI-DI for your IVD or medical device? The IVDR and MDR do not provide clear answers to this question. We have summarised several guidelines in a small tool for you. It will guide you through the most relevant questions you should ask yourself to find the most suitable solution.
AstraChange – the Tool for Significant Changes
The transition provisions of MDR Article 120(3) are especially hard to read. No wonder, that MDCG has published a guidance document (MDCG 2020-3) to help you decide whether your planned product change is considered significant or not. Our hard-working developers have turned the Guidance into a helpful tool for you. Try it now!
