SOMETIMES ALL YOU NEED IS THE RIGHT TOOL
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.
Coming soon: 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.